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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 (NCT00003701)

National Cancer Institute (NCI)
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 whether four-drug combination chemotherapy is more effective than two-drug combination chemotherapy in treating bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have bladder cancer.
  • Drug: carboplatin
    • Drug: cisplatin
      • Drug: doxorubicin hydrochloride
        • Drug: methotrexate
          • Drug: paclitaxel
            • Drug: vinblastine sulfate
              Ages eligible for Study
              Genders eligible for Study
              Accepts Healthy Volunteers
              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.

              13 locations

              United States (13)
              • Veterans Affairs Medical Center - Atlanta (Decatur)
                Not specified
                Decatur, Georgia, United States, 30033
              • Indiana University Hospitals
                Not specified
                Indianapolis, Indiana, United States, 46202
              • Hunterdon Regional Cancer Center
                Not specified
                Flemington, New Jersey, United States, 08822
              • Hackensack University Medical Center
                Not specified
                Hackensack, New Jersey, United States, 07601
              • South Jersey Hospital - Millville
                Not specified
                Millville, New Jersey, United States, 08332
              • Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
                Not specified
                Mount Holly, New Jersey, United States, 08060
              • Riverview Medical Center
                Not specified
                Red Bank, New Jersey, United States, 07701
              • Overlook Hospital
                Not specified
                Summit, New Jersey, United States, 07902-0220
              • Veterans Affairs Medical Center - New York
                Not specified
                New York, New York, United States, 10010
              • NYU School of Medicine's Kaplan Comprehensive Cancer Center
                Not specified
                New York, New York, United States, 10016
              • Cleveland Clinic Taussig Cancer Center
                Not specified
                Cleveland, Ohio, United States, 44195
              • Hahnemann University Hospital
                Not specified
                Philadelphia, Pennsylvania, United States, 19102-1192
              • Vanderbilt Cancer Center
                Not specified
                Nashville, Tennessee, United States, 37232-6838
              28 February, 1999
              01 November, 2010
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