Status:
COMPLETED
First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Bladder Cancer
Transitional Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin...
Eligibility Criteria
Inclusion
- Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic
- Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions:
- Calculated creatinine clearance ≤60 mL/min: OR
- New York Heart Association Classification Stage III-IV Congestive Heart Failure
- Measurable disease documented by imaging with at least one uni-dimensional lesion
- Adequate performance status (ECOG 0, 1, or 2)
- Men and women ≥18 years of age
Exclusion
- Patients in whom radiation or surgery is indicated
- Current neuropathy ≥ CTCAE grade 3
- Prior radiation to ≥ 30% of bone marrow
- Inadequate renal function: serum creatinine clearance ≤ 20 mL/min
- Prior allergy to any vinca alkaloid
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00389155
Start Date
January 1 2007
End Date
January 1 2008
Last Update
December 7 2015
Active Locations (112)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
3
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211
4
Local Institution
Concord, California, United States, 94520