Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• 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. Combination chemotherapy combined with transurethral resection may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of transurethral resection plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Doxorubicin; Liposomal doxorubicin; Methotrexate; Vinblastine

Criteria

DISEASE CHARACTERISTICS: Transitional cell carcinoma of the bladder with biopsy proven muscle invasion suitable for resection leaving no residual visible or palpable tumor mass Unifocal No greater than 5 cm Stages II and III (T2-T3a, N0-NX, M0) No prior treatment for bladder cancer other than endoscopic resection, intravesical chemotherapy, or intravesical immunotherapy

PATIENT CHARACTERISTICS: Age: Not specified Performance status: WHO 0-1 Life expectancy:

Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT normal Renal: GFR at least 50 mL/min Cardiovascular: Normal cardiac function (i.e., no New York Heart Association class II-IV) Other: Normal auditory function No second primary malignant tumor except basal cell carcinoma of the skin Fit for cisplatin containing combination chemotherapy, radical radiotherapy, or cystectomy No active infections Not pregnant or nursing No concurrent illness that significantly affects clinical assessments

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the bladder Surgery: See Disease Characteristics No prior partial cystectomy Prior transurethral resection of the bladder allowed