First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Bladder Cancer, Transitional Cell Carcinoma, Metastasis

In brief

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. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.

Key facts

Study ID

NCT00389155

Run by

Bristol-Myers Squibb

People needed

34

Starts

2007-01-01

Expected to finish

2008-01-01

Last updated by the study team

2015-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Acrc/Arizona Clinical Research Center, Inc. — Tucson, Arizona, United States
• Tower Hematology Oncology Medical Group — Beverly Hills, California, United States
• Local Institution — Concord, California, United States
• Glendale Memorial Hospital And Health Center — Glendale, California, United States
• Moores Ucsd Cancer Center — La Jolla, California, United States
• North Valley Hematology/Oncology Medical Group — Mission Hills, California, United States
• Local Institution — Orange, California, United States
• Stanford University — Stanford, California, United States
• Local Institution — Newark, Delaware, United States
• University Of Florida College Of Medicine At Jacksonville — Jacksonville, Florida, United States
• Local Institution — Jacksonville, Florida, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• University Of Miami — Miami, Florida, United States
• Advanced Medical Specialties — Miami, Florida, United States
• Medical College Of Georgia — Augusta, Georgia, United States
• Central Georgia Cancer Care, Pc — Macon, Georgia, United States
• University Of Chicago — Chicago, Illinois, United States
• Springfield Clinic, Llp — Springfield, Illinois, United States
• Michiana Hematology Oncology, P.C. — South Bend, Indiana, United States
• James Graham Brown Cancer Center — Louisville, Kentucky, United States
• Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins — Baltimore, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mitchell Folbe, Md, Pc — Troy, Michigan, United States
• Local Institution — Minneapolis, Minnesota, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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