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OpenTrials
Completed

NCT Number: NCT00389155

First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients 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.

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Key information

Conditions

Bladder Cancer Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Transitional Cell Carcinoma Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Local Institution, Tweed Heads, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vinflunine

Drug

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

Gemcitabine

Drug

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

Placebo

Other

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation

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

    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.

  6. 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

  7. 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

  8. 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

    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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 18, 2006
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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