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

Phase 2

Completed

• Conditions: Metastasis; Bladder Cancer; Transitional Cell Carcinoma
• Interventions: Drug: Vinflunine; Other: Placebo; Drug: Gemcitabine

• Registration Number: NCT00389155
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-18
• Study Start: 2007-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-10
• Disposition First Posted: 2010-09-13
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-06
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo and gemcitabine	Placebo	solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration
vinflunine and gemcitabine	Gemcitabine	solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
vinflunine and gemcitabine	Vinflunine	solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration
placebo and gemcitabine	Gemcitabine	solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Disease Control Rate in Participants With Best Response of CR, PR, or Stable Disease (SD)	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.
Number of Participants With Abnormal Laboratory Findings by Worst CTC Grade	Following Day 1 to no longer than 30 days after last dose of study medication
Duration of Response in Participants With Best Response of CR or PR	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.
Number of Participants With Outcome of Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Discontinuation	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.
Tumor Response Rate in Participants With A Best Response of Complete (CR) or Partial (PR) as Defined by RECIST criteria	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.
Time to Response in Participants With Best Response of CR or PR	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.
Overall Survival of Participants With TCC of the Urothelium	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.
Number of Participants With Serum Chemistry Abnormalities by Worst Common Terminology Criteria (CTC) Grade	Following Day 1 to no longer than 30 days after last dose of study medication

Trial Locations

Locations (58)

University Of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States

Acrc/Arizona Clinical Research Center, Inc.; 🇺🇸 Tucson, Arizona, United States

Tower Hematology Oncology Medical Group; 🇺🇸 Beverly Hills, California, United States

Local Institution; 🇬🇧 Birmingham, West Midlands, United Kingdom

Glendale Memorial Hospital And Health Center; 🇺🇸 Glendale, California, United States

Moores Ucsd Cancer Center; 🇺🇸 La Jolla, California, United States

North Valley Hematology/Oncology Medical Group; 🇺🇸 Mission Hills, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

University Of Florida College Of Medicine At Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Lakeland Regional Cancer Center; 🇺🇸 Lakeland, Florida, United States

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