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A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy

Phase 2/Phase 3
18 Years
Not Enrolling
Bladder Cancer, Transitional Cell Carcinoma, Metastasis

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Trial Information

A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Median Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria in Participants With Advanced Transitional Cell Carcinoma (TCC) of the Urothelium

Outcome Description:

PFS survival is defined as the time between randomization and the date of progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.

Outcome Time Frame:

Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

January 2008

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Carcinoma
  • Metastasis
  • Advanced or metastatic transitional cell carcinoma of the urothelium
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Neoplasm Metastasis



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