First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
- Conditions
- MetastasisBladder CancerTransitional Cell Carcinoma
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
-
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
- 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)
Medical College Of Georgia
🇺🇸Augusta, Georgia, United States
Nevada Cancer Centers
🇺🇸Las Vegas, Nevada, United States
Acrc/Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Local Institution
🇬🇧Birmingham, West Midlands, United Kingdom
Tower Hematology Oncology Medical Group
🇺🇸Beverly Hills, California, United States
Moores Ucsd Cancer Center
🇺🇸La Jolla, California, United States
Glendale Memorial Hospital And Health Center
🇺🇸Glendale, 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
Central Georgia Cancer Care, Pc
🇺🇸Macon, Georgia, United States
University Of Chicago
🇺🇸Chicago, Illinois, United States
Springfield Clinic, Llp
🇺🇸Springfield, Illinois, United States
Michiana Hematology Oncology, P.C.
🇺🇸South Bend, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Mitchell Folbe, Md, Pc
🇺🇸Troy, Michigan, United States
University Of Missouri Healthcare/Ellis Fischel Cancer Ctr
🇺🇸Columbia, Missouri, United States
Capital Comprehensive Cancer Care Center
🇺🇸Jefferson City, Missouri, United States
Washington University School Of Medicine
🇺🇸St. Louis, Missouri, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Hematology Oncology Centers Of The Northern Rockies, Pc
🇺🇸Billings, Montana, United States
The Cancer Center At Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
The Mary Imogene Bassett Hospital
🇺🇸Cooperstown, New York, United States
Albert Einstein Cancer Center
🇺🇸Bronx, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Mid-Ohio Oncology/Hematology, Inc. Dba
🇺🇸Columbus, Ohio, United States
Carolinas Hematology Oncology Associates
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Abramson Cancer Center Of The
🇺🇸Philadelphia, Pennsylvania, United States
Guthrie Foundation For Education And Research
🇺🇸Sayre, Pennsylvania, United States
The Jones Clinic, Pc
🇺🇸Germantown, Tennessee, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Cancer Specialists Of South Texas, Pa
🇺🇸Corpus Christi, Texas, United States
University Of Texas Medical Branch Of Galveston
🇺🇸Galveston, Texas, United States
The Center For Cancer And Blood Disorders
🇺🇸Fort Worth, Texas, United States
Northern Utah Associates
🇺🇸Ogden, Utah, United States
Cancer Outreach Associates, Pc
🇺🇸Abingdon, Virginia, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr
🇺🇸Seattle, Washington, United States
University Of Miami
🇺🇸Miami, Florida, United States
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Advanced Medical Specialties
🇺🇸Miami, Florida, United States
South Texas Oncology And Hematology, P.A.
🇺🇸San Antonio, Texas, United States
Mid Dakota Clinic, Pc
🇺🇸Bismarck, North Dakota, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
University Of Rochester
🇺🇸Rochester, New York, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Kansas City Veterans Affairs Medical Center
🇺🇸Kansas City, Missouri, United States
Medical University Of South Carolina
🇺🇸Charleston, South Carolina, United States
The Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Lone Star Oncology Consulants, Pa
🇺🇸Austin, Texas, United States