Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer

Status: Recruiting
Phase: Phase 3
Diagnosis: Bladder Cancer
NCT ID: NCT00942331 (View complete trial on
DFCI Protocol ID: 09-419


This randomized phase III trial is studying gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, cisplatin, and placebo in treating patients with advanced urinary tract cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given together with or without bevacizumab in treating patients with urinary tract cancer


Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Aymen Elfiky, MD, Dana Farber Cancer Institute

Site-responsible Investigators:
Richard J. Lee, MD, Massachusetts General Hospital
Frederick Briccetti, M.D., Dana Farber Cancer Institute at Londonderry Hospital

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068,
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264,
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514,

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra) - Unresectable or progressive metastatic or locally advanced disease (T4b, N2, N3 or M1) - Not a candidate for potentially curative surgery or radiotherapy - No history of peritoneal carcinomatosis - No known brain metastases PATIENT CHARACTERISTICS: - ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100% - ANC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Bilirubin ≤ 1.25 times upper limit of normal (ULN) (≤ 2.5 times ULN for patient's with Gilbert's disease) - AST ≤ 2.0 times ULN - Creatinine clearance ≥ 60 mL/min - Urine protein:creatinine ratio < 1.0 OR urine protein ≤ 1+ - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for up to 3 months after completion of study treatment - No NYHA class II-IV congestive heart failure - History of hypertension allowed provided it is well controlled (i.e., BP < 150/90 mm Hg) on a regimen of anti-hypertensive therapy - No arterial thrombotic events within the past 6 months, including any of the following: - Transient ischemic attack - Cerebrovascular accident - Peripheral arterial thrombus - Unstable angina or angina requiring surgical or medical intervention - Myocardial infarction - No clinically significant peripheral artery disease (i.e., claudication on < one block) - Deep venous thrombosis or pulmonary embolus within the past 6 months allowed provided patient is on stable therapeutic anticoagulation - No significant bleeding events (e.g., hemoptysis, upper or lower gastrointestinal [GI] bleeding, or grade 3 or 4 gross hematuria uncontrolled by transurethral resection of the bladder tumor) within the past 6 months - No GI perforation within the past 12 months - No serious or non-healing wound, ulcer, or bone fracture - No sensory or motor peripheral neuropathy ≥ grade 2 - No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies PRIOR CONCURRENT THERAPY: - At least 4 weeks since prior radiotherapy (including palliative radiotherapy) or major surgery and recovered - At least 4 weeks since prior intravesical therapy - No prior combination systemic chemotherapy for metastatic disease - Single-agent radiosensitizing chemotherapy is not considered prior systemic therapy - Prior neoadjuvant or adjuvant systemic chemotherapy allowed provided it was completed ≥ 1 year prior to the diagnosis of metastatic disease - No prior bevacizumab or other angiogenesis inhibitors - No concurrent radiotherapy (including palliative radiotherapy) - Concurrent full-dose anticoagulants allowed provided patient is on a stable dose of warfarin and has an in-range INR (between 2 and 3) OR is on a stable dose of low molecular weight heparin - Concurrent anti-platelet agents, daily prophylactic aspirin, or anticoagulation agents for atrial fibrillation allowed
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