Phase III Trial of Methotrexate, Vinblastine, Doxorubicin and Cisplatin vs Carboplatin and Paclitaxel in Advanced Carcinoma of the Urothelium
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Bruce J. Roth, MD
Study Chair
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
CDR0000066368
NCT00003376
September 1998
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
CCOP - Southwestern Vermont Regional Cancer Center | Bennington, Vermont 05201 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Lombardi Cancer Center, Georgetown University | Washington, District of Columbia 20007 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
University of Illinois at Chicago Health Sciences Center | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Togus | Togus, Maine 04330 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |