A Phase III Randomized Trial of Either M-VAC or Paclitaxel + Carboplatin as Postoperative Adjuvant Therapy in Patients With Muscle-Invasive Transitional Cell Carcinoma of the Bladder at High-Risk for Relapse
OBJECTIVES: I. Compare the recurrence rates and overall survival of patients treated with
postoperative adjuvant methotrexate, vinblastine, doxorubicin and cisplatin (M-VAC) to those
treated with combination paclitaxel and carboplatin for muscle invasive bladder cancer at
particularly high risk of relapse. II. Compare the relative toxicities of postoperative
M-VAC versus those encountered with postoperative paclitaxel and carboplatin. III. Compare
the quality of life scores during and following completion of treatment of patients in these
two treatment arms.
OUTLINE: This is a randomized study. Patients are stratified by N stage (N0 vs N+) and
performance status (0-1 vs 2). Patients are randomized to receive methotrexate, vinblastine,
doxorubicin, and cisplatin (arm I) or paclitaxel and carboplatin (arm II). Arm I: Patients
receive methotrexate IV push on days 1, 15, and 22; vinblastine IV push on days 2, 15, and
22; doxorubicin IV push on day 2; and cisplatin IV over 2 hours on day 2. Treatment repeats
every 28 days for 4 courses. Arm II: Patients receive paclitaxel IV over 3 hours on days 1
followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4
courses. Quality of life assessments are completed pretreatment, prior to course 3, 6 weeks
after the last dose of chemotherapy, and at 6, 12, and 24 months from the end of therapy.
Patients are followed every 3 months until year 2, every 6 months for years 2-5, and then
annually thereafter.
PROJECTED ACCRUAL: There will be 490 patients accrued into this study within 2.6 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Bruce J. Roth, MD
Study Chair
Vanderbilt-Ingram Cancer Center
United States: Federal Government
CDR0000066808
NCT00003701
March 1999
Name | Location |
---|---|
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
South Jersey Hospital - Millville | Millville, New Jersey 08332 |
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County | Mount Holly, New Jersey 08060 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Hunterdon Regional Cancer Center | Flemington, New Jersey 08822 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Riverview Medical Center | Red Bank, New Jersey 07701 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Indiana University Hospitals | Indianapolis, Indiana 46202 |