Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with cisplatin and radiation therapy and to see how well they work in treating patients with stage II or stage III bladder cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Collaborator: Groupe D'Etude des Tumeurs Uro-Genitales
• Treatments: Cisplatin; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of muscle invasive transitional cell carcinoma of the bladder

• T2-4a, N0, M0 (stage II or III disease)

• No adenocarcinoma or squamous cell carcinoma

PATIENT CHARACTERISTICS:

• WHO performance status (PS) 0-2 or Karnofsky PS 70-100%

• Life expectancy ≥ 6 months

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 10 g/dL

• Creatinine clearance ≥ 60 mL/min

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment

• No other prior malignancy, except previously treated nonmalignant skin cancer or carcinoma in situ of the cervix

• No prior serious digestive complications (e.g., ulcerative colitis or complicated diverticulosis)

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy or chemotherapy (except for intravesical instillations)