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Study Objectives Multicenter, open-label, dose-escalation and pharmacokinetic study. Conditions: Neoplasms Intervention / Treatment: DRUG: DpC Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Signed informed consent prior to initiation of any study-specific procedures; * Histologically or cytologically confirmed diagnosis of an advanced or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective, intolerable, or unacceptable for the patient; * At least one measurable lesion as defined by RECIST v1.1, except for patients with castrate resistant prostate cancer, who may be enrolled with objective evidence of disease per PCWG2 criteria, and patients with ovarian cancer who may be enrolled without measurable disease but who are evaluable by CA125 per GCIC criteria; * life expectancy at least 3 months; * ECOG performance status 0 <= age <= 1; * Adequate bone marrow reserve, cardiac, renal and liver function, defined by * absolute neutrophil count at least 1.5 x 10(9)/L; * platelet count at least 100 x 10(9)/L; * hemoglobin at least 9 g/dL; * ferritin at least 50 ug/L; * ECHO shows ejection fraction at least 50% and no evidence of cardiac dysfunction; * creatinine clearance >50 mL/min (Cockcroft & Gault formula); * AST/ALT no more than 3 x ULN (5 x ULN if liver or bone involvement); * serum albumin at least 28 g/L; * INR no more than 1.5 x ULN; * At least 3 weeks since chemotherapy, immunotherapy, hormone therapy, r other anticancer therapy or surgical intervention or at least 3 half-lie for monoclonal antibodies; * Patients with castrate-resistant prostate cancer must maintain ongoing androgen deprivation therapy to provide serum testosterone <50 mg/dL; * Patients receiving bisphosphonate or denosumab therapy must be on stable doses for at least 4 weeks before initiating study treatment. Exclusion Criteria: * Inability to swallow oral medications or presence of a GI disorder deemed to jeopardize intestinal absorption of DpC; * Persistent grade >1 clinically significant toxicities related to prior anticancer treatment (except alopecia); * Known primary CNS malignancy or CNS involvement (except for brain mets that have been treated and are stable and patient is off steroids); * History of prior to concomitant malignancies (other than fully excised non-melanoma skin cancer, cured in situ cervical carcinoma, early stage bladder cancer or DCIS of breast) within 3 years of study entry; * History of atrial fibrillation or evidence of atrial enlargement on baseline ECHO; * History of hemoglobinopathy; * Current use of iron chelation therapy; * Other serious illness or medial condition; * Participation in another clinical trial or treatment with any investigational drug within 30 days prior to study entry; * Current use of anticoagulants at therapeutic levels; * Pregnant or breast-feeding patients and men and women of child-bearing potential not using effective contraception while on study treatment

Study Objectives This is an open-label single photon emission computed tomography / computed tomography (SPECT/CT) study to investigate the safety and diagnostic performance of 99mTc-HYNIC-3PEG4-E\[c(RGDfK)2) (99mTc-3PRGD2) in esophagus cancer patients. A single dose of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion of esophagus cancer. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients. Conditions: Esophageal Cancer Intervention / Treatment: DRUG: 99mTc-3PRGD2 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Males and females, >=30 years * Thoracic CT and/or gastroscopy diagnosis in suspicion of primary or recurrent lung cancer. * The lung cancer will be histologically confirmed or results of histology will be available. Exclusion Criteria: * Females planning to bear a child recently or with childbearing potential * Known severe allergy or hypersensitivity to IV radiographic contrast. * Inability to lie still for the entire imaging time because of cough, pain, etc. * Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. * Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.

Study Objectives This phase I trial studies the side effects and best dose of wild-type reovirus (pelareorep) when given together with dexamethasone, carfilzomib, and nivolumab in treating patients with multiple myeloma that has come back (relapsed). Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. A virus, called pelareorep, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Giving dexamethasone, carfilzomib, and nivolumab with pelareorep may work better in treating patients with multiple myeloma. Conditions: Recurrent Plasma Cell Myeloma Intervention / Treatment: DRUG: Carfilzomib, DRUG: Dexamethasone, BIOLOGICAL: Nivolumab, BIOLOGICAL: Pelareorep Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patient must have multiple myeloma that fits or did fit International Myeloma Working Group (IMWG) diagnostic criteria * In arm 3 but not for arms 1 or 2, patients must have measurable disease defined as any of the following: * Serum monoclonal protein >= 0.5 g/dL by protein electrophoresis * >= 200 mg of monoclonal protein in the urine on screening 24-hour electrophoresis * If no m-spike is present, involved serum immunoglobulin free light chain >= 100 mg/L AND an abnormal serum light chain ratio (< 0.26 or > 1.65) * Progressive disease or clinical relapse at the time of study entry as defined by IMWG * Arm ONE only: Patients must be carfilzomib naive and have received >= 2 prior lines of therapy and must have included an IMiD, proteasome inhibitor, and anti-cluster of differentiation 38 (CD38) antibody as defined below * IMiD exposure: At least 1 cycle of prior treatment unless stopped due to intolerance * CD38 antibody exposure: At least 4 doses unless stopped due to intolerance * Proteasome inhibitor exposed: At least 1 cycle of prior treatment unless stopped due to intolerance * Arm TWO and THREE only: Patients must have received >= 3 prior lines of therapy and must have included an immunomodulatory imide drug (IMiD), proteasome inhibitor, and anti-CD38 antibody as above along with evidence of proteasome inhibitor resistance defined as less than or equal to stable disease with prior treatment with a proteasome inhibitor containing regimen at moderate doses defined as carfilzomib 27+ mg/m²/week (wk), bortezomib 1.3+ mg/m²/wk subcutaneously (SQ) or IV, or ixazomib 3+ mg/wk orally (PO) * Both men and women of all races and ethnic groups are eligible for this study * Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky > 60%) is required for eligibility. Those patients with lower performance status based solely on bone pain secondary to multiple myeloma are eligible * Prior autologous and/or allogeneic transplant is permitted although transplant must have occurred greater than 90 days prior to registration * Absolute neutrophil count (ANC) > 1000/µL for at least one week prior to screening * Platelet count >= 70,000 and platelet transfusion independent for one week prior to screening (platelets allowed to be down to 50,000 if > 50% plasma cells on screening aspirate or core biopsy) * Estimated creatinine clearance >= 30 mL/min as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or Cockcroft-Gault * Total bilirubin < 1.5 mg/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3x the institutional upper limit of normal * Left ventricular ejection fraction >= 40% * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy. The effects of pelareorep and nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * The patient must be willing to comply with fertility requirements as below: * Male patients must agree to use an adequate method of contraception for the duration of the study and for 7 months afterwards * Female patients must be either postmenopausal, free from menses >= 2 years, surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from heterosexual activity starting with screening and for 5 months after last treatment in all patients * Patients must agree not to donate blood, sperm/ova while taking protocol therapy and for at least 7 months after stopping treatment (for males) and 5 months after stopping treatment (for females) * Ability to understand and the willingness to sign a written informed consent document * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Exclusion Criteria: * Known human immunodeficiency virus (HIV) infection or active hepatitis B or C due to risk of viral infectivity of pelareorep * Known pulmonary hypertension * Patients who are receiving any other anti-myeloma investigational agents * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome, primary amyloidosis (AL amyloidosis), and Waldenstrom macroglobulinemia * Patients who have had anti-myeloma treatment, radiotherapy, plasmapheresis, or major surgery (as defined by the investigator) within 2 weeks prior to cycle 1 day 1 of the study. Patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg by mouth daily or its equivalent) for symptom management and comorbid conditions * Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction in the preceding 6 months, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because protocol therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to protocol treatment of the mother, breastfeeding should be discontinued

Study Objectives The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment Conditions: Actinic Keratosis Intervention / Treatment: DRUG: LEO 43204 gel, DRUG: Vehicle gel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest * Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area Exclusion Criteria: * Location of the treatment area (full face or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC * Treatment with ingenol mebutate gel in the treatment area within the last 12 months * Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions) * History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)

Study Objectives Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by concomitant administration of itraconazole in subjects with mesothelin-expressing advanced solid cancers Conditions: Medical Oncology Intervention / Treatment: DRUG: Anetumab ravtansine (BAY94-9343), DRUG: Itraconazole Location: Spain, Netherlands, Australia, United States, Belgium, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects must have histologically confirmed, locally advanced or metastatic solid cancers of the following histological types: 1. predominantly epithelial (>=50% tumor component) pleural or peritoneal mesothelioma 2. epithelial ovarian cancer (fallopian tube and primary peritoneal cancers are eligible) 3. adenocarcinoma of the pancreas, 4. triple-negative adenocarcinoma of the breast 5. non-small-cell adenocarcinoma of the lung 6. gastric cancer (including gastro-esophageal junction) 7. colon cancer 8. cholangiocarcinoma 9. Thymic carcinoma * Subjects must have no standard therapy available, or have actively refused standard therapy * Subjects must provide samples of archival tumor tissue collected and submitted anytime during the study * Subjects must have a life expectancy of at least 12 weeks * Subjects must have ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 * Subjects must have adequate bone marrow, renal and hepatic function and coagulation * Subjects must have normal or clinically insignificant ECG at screening * Women of reproductive potential must have a negative serum pregnancy test obtained within 3 days before the start of anetumab ravtansine * Women of childbearing potential and fertile men must agree to use adequate contraception when sexually active. This applies from the time period between signing of the informed consent until at least 6 months after the last administration of the last study drug. Male patients with a female partner of childbearing potential must use a condom and ensure that an additional form of contraception is also used during treatment and until 6 months after last study drug administration. Exclusion Criteria: * Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively treated >= 3 years before the start of anetumab ravtansine * New or progressive brain or meningeal or spinal metastases * Corneal epitheliopathy or any eye disorder that may predispose the subjects to drug-induced corneal epitheliopathy, or may interfere with diagnosis of treatment-emergent corneal epitheliopathy at the ophthalmologist's or the investigator's discretion * History or current evidence of * biliary cirrhosis * malignant biliary obstruction unless the bile flow to the gastrointestinal tract is maintained by a fully operational biliary stent * CTCAE (Common Terminology Criteria for Adverse Events) Grade >=2 bleeding disorder within 4 weeks before the start of anetumab ravtansine * uncontrolled cardiovascular disease or uncontrolled hypertension * Long QT Syndrome * HIV infection * Hepatitis B or C infection * Had a major surgery or significant trauma within 4 weeks before the start of anetumab ravtansine * Had solid organ or bone marrow transplantation * Have LVEF (left ventricular ejection fraction) <50% at screening * Have QTc >450 ms or heart rate >=100 bpm or <=45 bpm at screening * Poor CYP2D6 metabolizers based on the screening test for genetic polymorphisms in CYP2D6 metabolizing capacity

Study Objectives This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients will be recruited -14 who will receive placebo and 28 the study drug. Preliminary evidence indicates that this drug is safe and non-toxic in other disease states. Treatment with this drug holds promise not only for individuals with liver involvement, but also for many more patients with polycystic kidney disease. Conditions: Polycystic Kidney, Autosomal Dominant, Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Kidney, Polycystic, Abdominal Pain Intervention / Treatment: DRUG: Octreotide, DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Age - 18 years and older * Diagnosis of Polycystic Liver Disease (PLD) associated with ADPKD or isolated Autosomal Dominant Polycystic liver Disease (ADPLD) * Severe PLD defined as a liver volume greater than 4000 mL or symptomatic disease due to mass effects from hepatic cysts * Not a candidate for or declining surgical intervention Exclusion Criteria: * Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception * Creatinine greater than 3mg/dL or hemodialysis dependent * Cancer or major systemic disease that could prevent completion of the planned follow-up or interfere with data collection or interpretation * Uncontrolled diabetes mellitus as defined by blood glucose levels of greater than or equal to 250 mg/dL on 2 or more consecutive daily readings despite antidiabetic therapy * Neurologic/psychologic conditions preventing appropriate informed consent * Symptomatic gallstones or biliary sludge * Variceal bleeding or hepatic encephalopathy within prior 30 days * Uncontrolled hypertension (Systolic blood pressure greater than 160 mmHg; Diastolic blood pressure greater than 100 mmHg) * Current, or prior use of somatostatin analogue (octreotide, lanreotide) in past 6 months * History of significant adverse reaction to a somatostatin analogue

Study Objectives In this double-blinded randomized clinical trial study, investigators assessed probiotic used to prevent or delay radiation induced grade moderate to severe diarrhea with patient treated for pelvic cancer. Conditions: Cancer, Diarrhea, Abdominal Pain, Quality of Life Intervention / Treatment: DRUG: Bifilact®, OTHER: placebo Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * They had a pelvic cancer: gynecologic, rectal, or prostatic,they were to receive radiotherapy treatments for a minimum of 40 Gy at the pelvic level , with or without chemotherapy and they had Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1 Exclusion Criteria: * they had previous radiotherapy treatments in the pelvic or abdominal region, medical history of gastro-intestinal inflammation, malabsorption syndrome or inflammatory bowel disease or coeliac disease, ileostomy, daily use of anti-diarrheal medication before radiotherapy, pregnancy or breastfeeding, neutropenia or probiotics intolerance

Study Objectives Objectives * Primary: To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib * Secondary: To evaluate the efficacy and pharmacokinetics of FG-3019 in combination with gemcitabine and erlotinib Conditions: Locally Advanced or Metastatic Pancreatic Cancer Intervention / Treatment: DRUG: FG-3019 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Written informed consent * Males and females aged >=18 years * Histologically or cytologically confirmed adenocarcinoma of the pancreas * Locally advanced (Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas * Spiral CT scan demonstrating at least one pancreatic adenocarcinoma measurable lesion according to RECIST criteria and PET scan showing metabolically active lesion (for the last six subjects in the 15 mg/kg and the subjects in the 25 mg/kg FG-3019 dose cohorts only) * Women of childbearing potential and men must use effective contraception during and for at least 90 days following study participation. Women of childbearing potential must have a negative Screening serum pregnancy test. * ECOG performance status score of 0 <= age <= 1 * Life expectancy >12 weeks * Ability to adhere to the study visit schedule and understand and comply with all protocol requirements and instructions from study staff Exclusion Criteria * Absolute neutrophil count (ANC) <500 cells/mm3 * Hemoglobin <10.0 g/dL * Platelet count <100,000 cells/mm3 * Bilirubin >2.0 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5 x ULN, or >3.5 x ULN if liver metastases are present * If the subject is diabetic, HbA1c >10% * Current pregnancy or breast feeding due to recent pregnancy * History of another malignancy in the past 2 years with the exception of basal cell or squamous cell carcinoma of the skin * Previous chemotherapy with gemcitabine * Previous systemic antineoplastic agent (other than adjuvant 5-fluorouracil as radio-sensitizer) * Adjuvant 5-fluorouracil within 28 days prior to Day 1 * Major surgery within 28 days prior to Day 1 (stent placement is allowed) * Radiation therapy within 28 days prior to Day 1 * Clinical evidence or any history of brain metastasis * Uncontrolled hypertension (systolic blood pressure [SBP] >180 mmHg or diastolic blood pressure [DBP] >105 mmHg) * New York Heart Association Class III or IV congestive heart failure * History of allergic or anaphylactic reaction to human, humanized, or chimeric monoclonal antibodies * Current clinical or laboratory evidence of active infection requiring antibiotic or antiviral therapy * Active major gastrointestinal bleeding * Full-dose heparin therapy within 28 days prior to Day 1 * Participation in studies of investigational products within 42 days prior to Day 1 * Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study or a likelihood that the subject will be unable to comply with protocol requirements and complete the trial (e.g., emphysema requiring supplemental oxygen, poorly controlled arrhythmia, psychiatric illness, Alzheimer's disease) * Current abuse of alcohol or drugs

Study Objectives Exploratory study in adult males with metastatic prostate cancer intended to characterize the pharmacokinetics and biodistribution of PSMA-Targeted \[In-111\]-Labeled Trillium Compounds with and without the cytoprotective agent PTI-122. Up to 36 eligible subjects will be enrolled. Additional subjects may be enrolled if there is insufficient data for evaluation, for example if the original study subjects do not complete required imaging studies for reasons unrelated to adverse events. Up to four PSMA-Targeted \[In-111\]-Labeled Trillium Compounds will be evaluated. Each compound will be evaluated first without the cytoprotective agent, PTI-122, then the \[In-111\]-labeled Trillium Compound may be co-administered with PTI-122. Conditions: Prostate Cancer Intervention / Treatment: DRUG: PSMA-Targeted [In-111]-Labeled Trillium Compound, DRUG: PTI-122 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Adult males with metastatic prostate cancer * ECOG performance score 0 <= age <= 2 * Stable androgen deprivation or other hormone therapy (30 days) or therapy planned but not yet initiated * PSMA PET scan between 3 and 28 days prior to radiotracer injection with at least 2 PSMA positive lesions and either: 1. One soft tissue lesion measuring >= 15 mm in the longest diameter with SUVmax lesion >= SUVmean normal liver, OR 2. Two bone lesions measuring >= 15 mm in the longest diameter with SUVmax lesion >= 2 x SUVmax normal liver * Able to understand and adhere to study requirements, and voluntarily give informed consent Exclusion Criteria: * No other malignancy undergoing treatment * No PSMA-targeted therapy ongoing * Inability or unwillingness to undergo SPECT/CT imaging * Serum creatinine > 1.5 mg/dL or creatinine clearance <=50 mL/min by Cockcroft-Gault estimation * Concurrent participation in the active treatment phase of another clinical trial of investigational medicinal product(s) * Significant intercurrent illness, treatment-related toxicity, or psychiatric illness/social situation that could place the subject at undue risk during study participation, significantly alter study outcomes, or affect subject compliance with study requirements for dosing and evaluation, as determined by the investigator

Study Objectives Vascular endothelial growth factor is expressed in gastric cancer, and expression has been associated with more aggressive clinical disease. Vascular endothelial growth factor expression has been noted in 51% of gastric cancer specimens in one series (versus no expression in normal epithelium or superficial gastritis). Vascular endothelial growth factor expression in resected gastric cancer is associated with tumor recurrence and shorter survival. Maeda et al. studied 95 gastric cancer patients following resection with curative intent, and noted a significantly shorter survival in 34 patients whose tumor endothelium expressed VEGF (as detected via immunohistochemistry) versus 61 patients without endothelial VEGF expression (p\<0.05). Yoshikawa and colleagues observed similar survival differences in resected gastric cancer patients based on levels of circulating (plasma) VEGF at time of resection. Circulating VEGF is significantly higher in gastric cancer patients versus those without neoplasia. Elevated circulating VEGF was also associated with shorter survival in a European cohort undergoing gastric cancer resection; there was no survival beyond 30 months in 24 patients with serum VEGF \>533 pg/mL versus a 30-month survival rate \>35% for 34 patients with VEGF levels below this threshold (p\<0.0001, log-rank test). Recently, Jüttner and colleagues noted reduced survival following R0 resection in gastric cancer patients whose tumors expressed VEGF-C or VEGF-D, with the most robust association between expression and reduced survival for patients whose tumors expressed both VEGF-C and VEGF-D. Investigational inhibition of VEGF Receptor 2 in gastric cancer xenografts (TMK-1 cell line) is associated with reduced tumor growth. DC101 therapy in this model is associated with significant reductions in tumor vascularity (as measured by CD-31 expression) and increases in endothelial and tumor apoptosis. The results of the REGARD and RAINBOW studies are consistent with the idea that tumor- related angiogenesis contributes to the pathophysiology of gastric cancer and demonstrate the ability of ramucirumab to represent an improvement in the care of patients with gastric cancer whose disease has progressed after prior chemotherapy. Conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma Intervention / Treatment: DRUG: Ramucirumab, DRUG: Paclitaxel Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The patient has histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or GEJ adenocarcinoma. (Patients with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ.) * The patient has metastatic disease or locally recurrent, unresectable disease. * The patient has measureable or evaluable disease as determined by standard computed tomography (CT) or magnetic resonance imaging (MRI) imaging. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) (48). * The patient has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy for metastatic disease. * Acceptable prior chemotherapy regimens for this protocol are combination chemotherapy regimens that include platinum and/or fluoropyrimidine components (acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin; acceptable prior fluoropyrimidine agents are 5-FU, capecitabine, or S-1). Regimens including a third agent, such as an anthracycline or a taxane, are acceptable provided a fluoropyrimidine and/or a platinum were used. * Recurrence during or within 6 months of completion of adjuvant chemotherapy (capecitabine, 5-FU, or TS-1) will be considered as first-line chemotherapy. * The patient's disease is not amenable to potentially curative resection. * The patient is >=18 years. * The patient has resolution to Grade <=1 (or to Grade <=2 in the case of neuropathy) by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE), Version 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia). * The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. * The patient has adequate hepatic function as defined by a total bilirubin <=1.5 mg/dL (25.65 µmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) <= 3.0 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases). * The patient does not have: * cirrhosis at a level of Child-Pugh B (or worse) or * cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis. * The patient has adequate renal function as defined by a serum creatinine <=1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) >=40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed). * The patient's urinary protein is <=1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is >=2+, a 24-hour urine collection for protein must demonstrate <1000 mg of protein in 24 hours to allow participation in this protocol). * The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) >=1000/µL, hemoglobin >=9 g/dL (5.58 mmol/L), and platelets >=100,000/µL. * The patient must have adequate coagulation function as defined by international normalized ratio (INR) <=1.5 and a partial thromboplastin time (PTT) <=5 seconds above the ULN (unless receiving anticoagulation therapy). Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin. If receiving warfarin, the patient must have an INR <=3.0 and no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices). Patients on anticoagulation therapy with unresected primary tumors or local tumor recurrence following resection are not eligible. * If the patient has received prior anthracycline therapy as part of his or her first-line regimen, the patient is able to engage in ordinary physical activity without significant fatigue or dyspnea (equivalent to New York Heart Association Class I function) (49). * Because the teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods). * Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. * The patient is able to provide informed written consent. * Feasible biopsy site Exclusion Criteria: * The patient has documented and/or symptomatic brain or leptomeningeal metastases. * The patient has experienced any Grade 3 to 4 GI bleeding within 3 months prior to enrollment. * The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment. * The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the treating physician. * The patient has ongoing or active psychiatric illness or social situation that would limit compliance with treatment. * The patient has uncontrolled or poorly controlled hypertension (>160 mmHg systolic or >100 mmHg diastolic for >4 weeks) despite standard medical management. * The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment. * The patient has received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to enrollment. * The patient has received any investigational therapy within 30 days prior to enrollment. * The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment. * The patient has received prior therapy with an agent that directly inhibits VEGF (including bevacizumab), or VEGF Receptor 2 activity, or any antiangiogenic agent. * The patient is receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti- inflammatory drugs (NSAIDs; including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted. * The patient has elective or planned major surgery to be performed during the course of the clinical trial. * The patient has a known allergy to any of the treatment components. * The patient is pregnant or breastfeeding. * The patient is known to be positive for infection with the human immunodeficiency virus (HIV). * The patient has known alcohol or drug dependency. * The patient has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm. * The patient has a known hypersensitivity to ramucirumab or any of the excipients. * The patient may not have received more than 1 prior therapy in the metastatic setting.

Study Objectives Double blind, randomized, placebo-controlled, multicenter pilot study on efficacy and safety of CBLB612 following single administration for neutropenia prophylaxis in breast cancer patients receiving doxorubicin and cyclophosphamide myelosuppressive chemotherapy Conditions: Breast Cancer Intervention / Treatment: DRUG: CBLB612, DRUG: Placebo Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Written informed consent for the study participation. * Women in the age above 18 years inclusively. * Patients with histologically proven diagnosis of breast cancer to which the 1-st cycle of AC chemotherapy treatment is indicated (with 3-week interval). * ECOG Performance Status of 0 <= age <= 2. * Life expectancy >= 6 months. * Completion of all previous cancer therapies (including surgery, radiotherapy, chemotherapy, immunotherapy or study therapy) not later than 4 weeks prior the CBLB612 study. * All acute toxic effects of any previous therapies <Grade 1 prior the study, except for alopecia and/or neurotoxicity (Grade 1 or 2 is allowed). * Adequate hematopoiesis function: * WBC >=3.0 x 103/μl; * PTT >=1.5 x 103/μl; * Platelets >=75 x 103/μl; * Hemoglobin >=10 g/dl. * Adequate hepatic function: * Total bilirubin <=1.5 x ULN; * ALT and AST <=3 x ULN; * Alkaline phosphatase <=2.5 x ULN. * Adequate renal function: * Creatinine <=1.5 x ULN. * Adequate values of hemostasis system: * Prothrombin time; * <=1.5 x ULN; * Activated partial thromboplastin time <=1.5 x ULN; * INR <=1.5 x ULN. * Adequate cardiac function which means * LVEF >=45 based on ultrasonic examination of the heart or radionuclide angiography; * 12-lead electrocardiogram (ECG) with normal tracing, non-clinically significant changes may occur that do not require medical intervention. * Negative test for serological infection markers: * Negative HIV-antibody test; * Negative test for hepatitis B surface antigen (HBsAg); * Negative test for hepatitis C virus antibodies or negative test for mRNA of hepatitis C virus; * Negative test for Treponema pallidum antibodies. * Negative pregnancy test. * Consent of a patient with preserved reproductive function to use effective contraception method since screening up to at least 3 months after the study therapy. * e.g. intrauterine device, oral contraceptive, subcutaneous implant or double-barrier method (condom with contraceptive sponge or contraceptive vaginal suppository). * A patient shall be ready and able to meet the requirements of the study protocol and have the opportunity to participate in the study throughout the scheduled period. Exclusion Criteria: * Rapidly progressing, clinically unstable breast cancer with present clinical signs of cerebral or meningeal membrane metastases. * Specific contraindications or hypersensitivity data in relation to any of the following drugs: doxorubicin, cyclophosphamide, CBLB612, anti-emetic agents (aprepitant, palonosetron), anti-inflammatory drugs (including paracetamol and aspirin), as well excipients of the abovementioned drug agents including polysorbate 80. * History of febrile neutropenia. * Presence of autoimmune disease. * Acute or chronic/relapsing inflammatory eye disease or any other significant eye disorder. * patients with mild and moderate myopia or hypermetropia, or presbyopia may be enrolled to the study. * Pregnancy or breast feeding, refusal to use adequate contraception methods during the study. * Signs of ongoing systemic bacterial, fungal or viral infectious disease or local infection requiring treatment at the randomization. * patients with local fungal lesion of skin area or nail may be enrolled to the study. * Systemic antibiotic therapy during up to 72 hours prior the randomization. * Previous radiotherapy of >=30% of bone marrow. * Surgery or chemotherapy or experimental drug therapy within 4 weeks prior randomization. * Transplantation of bone marrow or peripheral blood precursor cells. * Intake of more than 10 portions of alcoholic beverages per week or anamnestic data on alcoholism, narcomania, drug abuse. * one portion of alcoholic beverage is 250 ml of beer, 125 ml of wine or 30 ml of strong alcoholic beverage. * Current immunosuppressant therapy including systemic corticosteroid therapy. * Clinically significant abnormal vital signs, results of laboratory and instrumental tests, based on the investigator assessment. * Any disease, condition, organ dysfunction or central nervous system disorder of the intake of narcotic drugs which, according to the investigator, may affect ability to participate in the study or hinder assessment of study results.

Study Objectives Phase 1: To assess the safety, tolerability, and maximum tolerated dose (MTD)/ recommended dose of ganetespib when administered in combination with sirolimus in patients with refractory or relapsed sarcomas including unresectable or metastatic sporadic or neurofibromatosis type 1 (NF1) associated MPNST. Phase I enrollment has been closed. Phase 2: To determine the clinical benefit of ganetespib in combination with sirolimus for patients with unresectable or metastatic sporadic or NF1 associated MPNST. Conditions: Malignant Peripheral Nerve Sheath Tumors (MPNST), Sarcoma Intervention / Treatment: DRUG: ganetespib, DRUG: Sirolimus Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients >= 16 years * Patients with unresectable or metastatic histologically confirmed sporadic or NF1 associated high grade MPNST * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Patients must have at least 1 measurable tumor * Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy (toxicity < grade 2) * Must be able to swallow whole pills * Adequate organ function * Normal fasting cholesterol and triglycerides * May be on cholesterol medications Exclusion Criteria: * Patients receiving current treatment with corticosteroids or another immunosuppressive. Topical or inhaled corticosteroids are allowed. * Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases * Symptomatic congestive heart failure * Severely impaired lung function * Significant vascular disease * Uncontrolled diabetes * Active (acute or chronic) or uncontrolled severe infections hepatitis * Impairment of gastrointestinal function * Patients with an active, bleeding diathesis or significant coagulopathy * Use of cytochrome P450 isoenzyme 3A4 (CYP3A4)/ CYP2C19 substrates

Study Objectives This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied. Conditions: Carcinoma, Transitional Cell Intervention / Treatment: DRUG: Rogaratinib (BAY1163877), DRUG: Chemotherapy Location: Spain, Sweden, Taiwan, Netherlands, Australia, Poland, United States, Belgium, France, Finland, United Kingdom, Russian Federation, Portugal, Singapore, Canada, Czechia, Slovakia, Denmark, Japan, Hong Kong, Korea, Republic of, Austria, Switzerland, Hungary, Ireland, Israel, Germany, China, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Existence of archival or fresh biopsy for FGFR testing. Mandatory FGFR testing of patients will be performed prior to start of screening. The timing of the FGFR test is at the discretion of the investigator. Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment. * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically confirmed (Patients with mixed histologies are required to have a dominant transitional cell pattern.) * Locally advanced (T4, any N; or any T, N 2 <= age <= 3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2 <= age <= 3). * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1 * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment. * High FGFR1 or 3 mRNA expression levels in archival or fresh tumor biopsy specimen quantified as outlined in the lab manual * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI Exclusion Criteria: * Previous or concurrent cancer except * cervical carcinoma in situ * treated basal-cell or squamous cell skin carcinoma * any cancer curatively treated > 3 years before randomization * curatively treated incidental prostate cancer (T1/T2a) * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFR-specific antibodies) or with taxanes or vinflunine * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma given for advanced unresectable/ metastatic disease * Ongoing or previous anti-cancer treatment within 4 weeks before randomization. * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2 * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization) * Myocardial infarction (MI) within past 6 months before randomization * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible. * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia) * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion * Any hemorrhage / bleeding event >= CTCAE v.4.03 Grade 3 within 4 weeks before randomization

Study Objectives This phase II trial is studying how well vismodegib works in treating adult patients with recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells and may be an effective treatment for medulloblastoma. Conditions: Adult Medulloblastoma Intervention / Treatment: OTHER: Pharmacological Study, DRUG: Vismodegib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with a histologically confirmed diagnosis of medulloblastoma (including posterior fossa PNET) that is recurrent, progressive, or refractory to standard therapy and for which there is no known curative therapy are eligible; there must be evidence of residual measurable disease or lesion in pre-study MRI as described in section; patients with spinal disease that is measurable will be eligible * The diagnosis should be confirmed at the treating institution and tissue (either from the diagnosis or relapse or preferably from both time points) must be available for biological studies * Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration; this is to be documented in the database * Eastern Cooperative Oncology Group (ECOG) performance status 0- 2 * No other myelosuppressive chemotherapy or immunotherapy within 4 weeks prior to study entry (6 weeks if prior nitrosourea) * Decadron dose should also be stable or decreasing for at least 1 week (7days) prior to starting therapy * Radiation therapy (XRT) >= 3 months prior to study entry for craniospinal irradiation (>= 23 Gy); >= 8 weeks for local irradiation to primary tumor; >= 2 weeks prior to study entry for focal irradiation for symptomatic metastatic sites * Off all colony stimulating factors >= 1 week prior to study entry (GCSF, GM CSF, erythropoietin) * Absolute neutrophil count (ANC) >= 1000/μL * Platelet count >= 50,000/uL (transfusion independent) * Hemoglobin >= 8.0 gm/dL (may receive RBC transfusions) * Creatinine clearance or radio-isotope GFR >= 70ml/min/1.73 m2 or * A serum creatinine =< 2.0 mg/dL * Total bilirubin =< 1.5 x upper limit of normal (ULN) for age * Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x institutional ULN * Serum glutamic-oxalacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 times institutional ULN * Serum albumin >= 2.5 g/dL * Patient must have recovered from the significant acute toxicities of all prior therapy before entering this study and meet all other eligibility criteria * Pregnancy should be avoided for 12 months after the last dose of GDC-0449 for females of child-bearing potential; female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to beginning treatment * Women of childbearing potential are required to use 2 forms of acceptable contraception, including one barrier method during participation in the study and for the 12 months following the last dose; for medical or personal reasons, 100% commitment to abstinence is considered an acceptable form of birth control. All patients should receive contraceptive counseling either by the investigator, or by an OB/gynecologist or other physician who is qualified in this area of expertise; prior to dispensing GDC-0449, the investigator must confirm and document the patient's use of two contraceptive methods, dates of negative pregnancy test, and confirm the patient's understanding of the of GDC-0449 to cause spontaneous abortion or birth defects * Signed informed consent according to institutional guidelines must be obtained Exclusion Criteria: * Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that would compromise the patient's ability to tolerate protocol therapy or would likely interfere with the study procedures or results * Patients receiving any other anticancer or investigational drug therapy * Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy * Life expectancy < 12 weeks as determined by treating physician * Inability to swallow capsules * Prior treatment with GDC-0449 or other antagonists of the HH pathway * Malabsorption syndrome or other condition that would interfere with enteral absorption * History of congestive heart failure * History of ventricular arrhythmia requiring medication * Uncontrolled hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia defined as less than the lower limit of normal for the institution despite adequate electrolyte supplementation * Congenital long QT syndrome

Study Objectives RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Green tea extract (Polyphenon® E) contains certain ingredients that may slow the growth of tumor cells and prevent the recurrence of cancer. Giving erlotinib or green tea extract after surgery may kill any remaining tumor cells and may prevent the recurrence of bladder cancer. PURPOSE: This randomized phase II trial is studying how well giving erlotinib together with green tea extract works in preventing cancer recurrence in former smokers who have undergone surgery for bladder cancer. Conditions: Bladder Cancer Intervention / Treatment: DIETARY_SUPPLEMENT: Polyphenon E, DRUG: erlotinib hydrochloride, OTHER: Erlotinib placebo, OTHER: Polyphenon E Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Participants must be former smokers and have ceased smoking at study entry. * Participants with any previous history of prior cancer diagnosis of Grade 1, 2, or 3, Ta or T1 papillary TCC, or CIS TCC, histologically confirmed, with a newly diagnosed or recurrent tumor within 6 months of accrual who are rendered disease free by standard of care. Patients with Grade 1 papillary tumors must meet at least one of the following additional criteria: 1. multiple, synchronous tumors (>2) 2. a single tumor greater than 1 cm in size * At study entry, patients must have no evidence of disease * Participants may have been previously treated with intravesical therapy. * Age>18 years * Transurethral resection of bladder tumor within 6 months prior to entry on to study * Participants must have a signed written informed consent * Agreement with complete abstinence from heterosexual intercourse or with the use of contraception during the treatment phase in women of childbearing potential * Negative pregnancy test in women of childbearing potential * Patients must have adequate bone marrow function at study entry (WBC>3000, platelets>100000/mm3, and hemoglobin>10g/dl) * Patients must have satisfactory renal and hepatic function, defined as plasma creatinine of < 1.5mg/dl, total bilirubin < 1.5, and AST/ALT < 1.5 x the upper limit of normal * Patients with evidence of obstructive lung disease as the etiology of a low diffusing capacity will still be eligible as long as the chest radiograph does not demonstrate interstitial changes Exclusion Criteria: * Prior chemotherapy or radiotherapy * Prior (within 2 years) or concurrent malignancies, except non-melanomatous skin tumors or carcinoma in situ of the cervix * Significant medical or psychiatric condition that would make the participant a poor protocol candidate * TCC greater than or equal to T2 at most recent diagnosis * Involvement of the upper urinary tract prior to or at the time of initial tumor resection * Prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study drug and for the duration of the study * Positive pregnancy test at any time throughout the course of the study * Normal consumption of greater than 5 cups of green tea daily * Participants taking a known CYP 3A4 inducer or food products and medications known to be inhibitors or metabolized by CYP3A4/5 such as erythromycin, ketoconazole, etc. will be excluded since these drugs may be expected to result in altered exposure of Erlotinib * ECOG performance status > 1 * History of idiopathic pulmonary fibrosis or other interstitial lung disease * Use of tricyclic antidepressants, including imipramine, dothiepin, and mianserin * Use within the last 12 months of amiodarone, methotrexate, isoniazid, minocycline, or nitrofurantoin * History of environmental or occupational metal dust or wood dust exposure * History of connective tissue disease, including scleroderma, rheumatoid arthritis, Sjogren's Syndrome, or sarcoid * Significant ophthalmologic abnormalities or patients using contact lenses * Evidence of interstitial lung disease on chest radiograph * Patients without obvious interstitial lung disease on chest radiograph will be excluded if they have evidence of parenchymal restrictive lung disease on pulmonary function testing as identified by the following criteria: 1. Both vital capacity and total lung capacity <80% of predicted value 2. A diffusing capacity of the lung for carbon monoxide, corrected for hemoglobin, < 75% of predicted value

Study Objectives The purpose of this study is to determine the pathological complete tumor response rate. Conditions: Rectal Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: Oxaliplatin Location: Switzerland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal involvement requiring surgery of the primary tumor * Eastern Cooperative Oncology Group performance status 0 <= age <= 2 * Adequate values of laboratory parameters Exclusion Criteria: * Evidence of distant metastases * Previous Chemotherapy or immunotherapy for colorectal cancer * Previous radiotherapy to the pelvis * Pre-existing condition which would deter radiotherapy * Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix * Clinically significant cardiac disease or myocardial infarction within the last 12 months * Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome * Organ allografts * Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues * Dihydropyrimidine dehydrogenase (DPD) deficiency * History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake