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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00389155
First received: October 17, 2006
Last updated: December 22, 2010
Last verified: December 2010

October 17, 2006
December 22, 2010
January 2007
January 2008   (final data collection date for primary 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 [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
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.
To compare Progression-Free Survival
Complete list of historical versions of study NCT00389155 on ClinicalTrials.gov Archive Site
  • Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    Tumor response rate is defined as the number of participants in that arm whose best response is PR or CR, divided by the total number of randomized participants in the arm.
  • Overall Survival of Participants With TCC of the Urothelium [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    Survival duration is defined as the time (in months) from randomization until death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive.
  • Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD) [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    Disease control rate is defined as the number of participants in that arm whose best response is PR, CR, or SD, divided by the total number of randomized participants in the treatment arm.
  • Duration of Response in Participants With Best Response of CR or PR [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    Duration of response is computed for participants with best response of CR or PR; the duration is measured from the time measurement criteria are met for CR or PR, whichever is recorded first, until the date of documented progressive disease or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.
  • Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation [ Designated as safety issue: Yes ]
    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.
  • Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade [ Time Frame: Following Day 1 to no longer than 30 days after last dose of study medication ] [ Designated as safety issue: Yes ]
  • Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade [ Time Frame: Following Day 1 to no longer than 30 days after last dose of study medication ] [ Designated as safety issue: Yes ]
  • Time to Response in Participants With Best Response of CR or PR [ Time Frame: Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision ] [ Designated as safety issue: No ]
    Time to response is defined as the number of months from the first dose of study therapy until measurement criteria are met for PR or CR, whichever is recorded first.
  • To compare the response rate
  • To compare Overall Survival
  • To compare disease control rate
  • To estimate the duration of response
  • To estimate time to response
  • To evaluate the safety profile
Not Provided
Not Provided
 
First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Bladder Cancer
  • Transitional Cell Carcinoma
  • Metastasis
  • Drug: vinflunine and gemcitabine
    solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
  • Drug: placebo and gemcitabine
    solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
  • Experimental: 1
    Intervention: Drug: vinflunine and gemcitabine
  • Placebo Comparator: 2
    Intervention: Drug: placebo and gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy,   Spain,   Indonesia,   Russian Federation,   United Kingdom,   Greece,   Thailand,   Poland,   France,   Korea, Republic of,   Denmark,   Philippines,   Australia,   Belgium,   Canada
 
NCT00389155
CA183-002
Yes
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP