4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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 combination chemotherapy is more effective than observation alone in treating bladder cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy to see how well it works compared to observation alone in treating patients with bladder cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: National Cancer Institute (NCI); NCIC Clinical Trials Group; University of Southern California
• Treatments: Cisplatin; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vinblastine

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven organ confined transitional cell carcinoma (TCC) of the bladder

• Must have undergone radical cystectomy and bilateral pelvic lymphadenectomy with pathologic stage from definitive cystectomy specimen of P1, P2a, or P2b and N0, M0 TCC with or without squamous/glandular differentiation (no adenocarcinoma, squamous cell carcinoma, or small cell carcinoma)

• Margins must be negative for invasive or in situ TCC

• In situ TCC in the urethra or ureter(s) allowed provided margins are negative

• Clinical stage T1, T2a, or T2b based on transurethral resection bladder tumor specimen with P0 or PIS and N0, M0 TCC allowed

• Incidental pT2a (Gleason score no greater than 7), pT2b (Gleason score no greater than 7), or pT2c (Gleason score no greater than 7) adenocarcinoma of the prostate allowed

• No invasive tumor into ureter(s) or urethra

• Must have potentially curable disease

• Must register within 9 weeks after surgery

• No metastatic disease by physical exam and chest x-ray or CT scan of the chest

• Eligible for randomization if:

• p53 gene alteration present

• Randomization occurs within 10 weeks after surgery

• Those who are randomized to receive (MVAC) methotrexate, vinblastine, doxorubicin, and cisplatin begin MVAC within 12 weeks after cystectomy

• No metastatic disease by physical exam and chest x-ray or CT scan of the chest

• No prohibitive medical risk for chemotherapy

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• ECOG 0-1 OR

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 4,000/mm^3

• Platelet count at least 150,000/mm^3

Hepatic

• SGOT or SGPT no greater than 2 times normal

• Alkaline phosphatase no greater than 2 times normal

• Bilirubin normal

Renal

• Creatinine no greater than 1.8 mg/dL OR

• Creatinine clearance at least 50 mL/min

• Blood urea nitrogen normal

Cardiovascular

• No serious arrhythmias

• No congestive heart disease with New York Heart Association class III or IV status

• Randomization group:

• Ejection fraction must be at least 50% by MUGA scan if there is a clinical concern regarding the patient's cardiac status

Other

• No other malignancy (including synchronous papillary or invasive upper urinary tract malignancy) within the past 5 years except incidental prostate cancer (found at cystectomy), basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix

• No concurrent advanced medical illness or psychologic disease

• No prohibitive medical risk for chemotherapy

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• No prior systemic chemotherapy for bladder cancer

• At least 5 years since other prior systemic chemotherapy

• Prior intravesical therapy allowed

• Randomization group:

• Prior intravesical therapy allowed if administered prior to cystectomy

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic irradiation

Surgery

• See Disease Characteristics