Spots Global Cancer Trial Database for Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
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Trial Identification
Brief Title: Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
Official Title: Phase III Trial of Methotrexate, Vinblastine, Doxorubicin and Cisplatin vs Carboplatin and Paclitaxel in Advanced Carcinoma of the Urothelium
Study ID: NCT00003376
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if four-drug combination chemotherapy is more effective than two-drug combination chemotherapy in treating advanced cancer of the urothelium. PURPOSE: Randomized phase III trial to compare the effectiveness of four-drug combination chemotherapy with that of two-drug combination chemotherapy in treating patients who have advanced cancer of the urothelium.
Detailed Description: OBJECTIVES: I. Compare the objective response rate, duration of remission, overall survival, and quality of life of patients with progressing regional or metastatic transitional cell carcinoma (or mixed histologies with a component of transitional cell carcinoma) of the urothelium treated with methotrexate, vinblastine, doxorubicin, and cisplatin vs carboplatin and paclitaxel. II. Compare the relative toxic effects of these treatment regimens in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive methotrexate IV on days 1, 15, and 22; vinblastine IV on days 2, 15, and 22; and cisplatin IV over 2 hours and doxorubicin IV on day 2. Treatment repeats every 28 days for a total of 6 courses in the absence of unacceptable toxicity or disease progression. Arm II: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for a total of 6 courses in the absence of unacceptable toxicity or disease progression. Quality of life is assessed before treatment, before courses 2 and 4, at 4 weeks after last course, and at 10 months. Patients are followed every 3 months for 1 year and then every 6 months until disease progression. PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study within 3.3 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, United States
University of California San Diego Cancer Center, La Jolla, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States
CCOP - Christiana Care Health Services, Wilmington, Delaware, United States
Lombardi Cancer Center, Georgetown University, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Illinois at Chicago Health Sciences Center, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Veterans Affairs Medical Center - Togus, Togus, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York, United States
Mount Sinai Medical Center, NY, New York, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham, Durham, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
University of Tennessee, Memphis Cancer Center, Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, United States
CCOP - Southwestern Vermont Regional Cancer Center, Bennington, Vermont, United States
Vermont Cancer Center, Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont, United States
Veterans Affairs Medical Center - Richmond, Richmond, Virginia, United States
MBCCOP - Massey Cancer Center, Richmond, Virginia, United States
Contact Details
Name: Bruce J. Roth, MD
Affiliation: Vanderbilt-Ingram Cancer Center
Role: STUDY_CHAIR
Name: Martin J. Edelman, MD
Affiliation: Veterans Affairs Medical Center - Baltimore
Role: STUDY_CHAIR
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