First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2007 |
| End Date: | January 2008 |
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.
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.
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
We found this trial at
65
sites
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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University of Miami A private research university with more than 15,000 students from around the...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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