Brief Title
First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
Official Title
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
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. 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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
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
Secondary Outcome
Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria
Condition
Bladder Cancer
Intervention
Vinflunine
Study Arms / Comparison Groups
vinflunine and gemcitabine
Description: solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
34
Start Date
January 2007
Completion Date
January 2008
Primary Completion Date
January 2008
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bristol-Myers Squibb, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00389155
Organization ID
CA183-002
Responsible Party
Sponsor
Study Sponsor
Bristol-Myers Squibb
Study Sponsor
Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
Verification Date
November 2015