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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Bladder Cancer  Combination Chemotherapy in Treating Patients With Bladder Cancer
Combination Chemotherapy in Treating Patients With Bladder Cancer
For Condition: stage 3 bladder cancer,childhood kidney/urinary cancer,urethral cancer associated with invasive bladder cancer,transitional cell carcinoma of the bladder
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BruceRoth, Study Chair, Eastern Cooperative Oncology Group
Riverview Medical Center
Red Bank, New Jersey, 07701
United States
South Jersey Hospital - Millville
Millville, New Jersey, 08332
United States
Veterans Affairs Medical Center - New York
New York City, New York, 10010
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
Overlook Hospital
Summit, New Jersey, 07902-0220
United States
Indiana University Hospitals
Indianapolis, Indiana, 46202
United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Additional Information:
Study ID Numbers: CDR0000066808; E-1897
Study Start Date: March 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003701
Other Stage 3 Bladder Cancer Studies:
1. Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium
2. Radiation Therapy and Chemotherapy Following Surgery in Treating Patients With Stage II or Stage III Bladder Cancer
3. Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
4. Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
5. Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
Related Studies:
Other stage 3 bladder cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Combination Chemotherapy in Treating Patients With Bladder Cancer
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