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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003701 |
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.
Condition | Intervention | Phase |
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Bladder Cancer Urethral Cancer |
Drug: carboplatin Drug: cisplatin Drug: doxorubicin hydrochloride Drug: methotrexate Drug: paclitaxel Drug: vinblastine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | 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 |
Estimated Enrollment: | 490 |
Study Start Date: | March 1999 |
Primary Completion Date: | August 2001 (Final data collection date for primary outcome measure) |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the bladder or mixed histologies containing a component of transitional cell carcinoma Must have undergone radical cystectomy and pelvic lymph node dissection within 12 weeks prior to randomization No evidence of distant metastatic disease on pre- or postoperative radiographic scans No positive surgical margins in the cystectomy specimen and no known macroscopic residual disease left at time of cystectomy No bladder sparing surgery May have undergone continent urinary diversion or neobladder procedure but must have recovered completely from the effects of surgery Must have muscle-invasive disease on final pathologic staging and have a primary tumor stage of pT4, any N, M0, or any pT, N+, M0, or pT3b, any N, any M, and following a pelvic lymph node dissection have a pathologic nodal stage of pN0 (only if pT3b or pT4), pN1, or pN2 Clinically unsuspected organ confined prostate cancer found during cystoprostatectomy allowed
PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 1.7 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No second degree atrioventricular block or bundle branch block Other: No history of prior malignancy in the past 5 years except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix No active infection requiring antibiotics No history of allergic reaction to drugs utilizing the vehicle Cremophor Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Recovered from all prior therapies Biologic therapy: No prior biologic response modifier therapy No filgrastim (G-CSF) 24 hours pre- or post-chemotherapy administration Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy as a component of bladder sparing therapy No prior adjuvant radiotherapy for locally advanced disease with positive margins Surgery: See Disease Characteristics Other: Prior intravesical therapy for superficial bladder cancer allowed and recovered
United States, Georgia | |
Veterans Affairs Medical Center - Atlanta (Decatur) | |
Decatur, Georgia, United States, 30033 | |
United States, Indiana | |
Indiana University Hospitals | |
Indianapolis, Indiana, United States, 46202 | |
United States, New Jersey | |
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County | |
Mount Holly, New Jersey, United States, 08060 | |
Overlook Hospital | |
Summit, New Jersey, United States, 07902-0220 | |
Hunterdon Regional Cancer Center | |
Flemington, New Jersey, United States, 08822 | |
Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
Riverview Medical Center | |
Red Bank, New Jersey, United States, 07701 | |
South Jersey Hospital - Millville | |
Millville, New Jersey, United States, 08332 | |
United States, New York | |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
New York, New York, United States, 10016 | |
Veterans Affairs Medical Center - New York | |
New York, New York, United States, 10010 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Hahnemann University Hospital | |
Philadelphia, Pennsylvania, United States, 19102-1192 | |
United States, Tennessee | |
Vanderbilt Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 |
Study Chair: | Bruce J. Roth, MD | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000066808, E-1897 |
Study First Received: | November 1, 1999 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00003701 History of Changes |
Health Authority: | United States: Federal Government |
stage III bladder cancer transitional cell carcinoma of the bladder urethral cancer associated with invasive bladder cancer |
Antimetabolites Urinary Tract Neoplasm Immunologic Factors Urogenital Neoplasms Vinblastine Urologic Neoplasms Carcinoma, Transitional Cell Anti-Bacterial Agents Urologic Diseases Cisplatin Urethral Cancer Methotrexate Bladder Neoplasm Cystocele Urinary Bladder Diseases |
Urinary Bladder Neoplasms Adjuvants, Immunologic Antimitotic Agents Carboplatin Folic Acid Antagonists Immunosuppressive Agents Doxorubicin Carcinoma Folic Acid Paclitaxel Tubulin Modulators Urethral Neoplasms Antirheumatic Agents Antineoplastic Agents, Phytogenic Transitional Cell Carcinoma |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Vinblastine Reproductive Control Agents Urologic Neoplasms Carcinoma, Transitional Cell Antibiotics, Antineoplastic Neoplasms by Site Urologic Diseases Therapeutic Uses |
Abortifacient Agents Urethral Diseases Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Antimitotic Agents Carboplatin Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents |