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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bladder Cancer; Metastasis; Transitional Cell Carcinoma

Treatments: Other: Placebo; Drug: Gemcitabine; Drug: Vinflunine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00389155

CA183-002

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

vinflunine and gemcitabine

Experimental group

Description:

solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration

Treatment:

Drug: Gemcitabine

Drug: Vinflunine

placebo and gemcitabine

Placebo Comparator group

Description:

solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration

Treatment:

Drug: Gemcitabine

Other: Placebo