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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Cisplatin; Gemcitabine; Pharmaceutical Solutions; Vinblastine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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