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

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

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