Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy and surgery may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer that can be removed by surgery.

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

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Gemcitabine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage II or III (T2-4a, Nx or N0, M0) primary carcinoma of the bladder with muscle invasion

• Resectable disease

• Prostatic urethral involvement with transitional cell carcinoma allowed, if completely resected and no evidence of stromal invasion

• No tumor-related hydronephrosis

• Positive lymph node must be evaluated by lymphadenectomy or percutaneous needle biopsy

• No nodal metastases

• No distant metastases

• No more than 6 weeks since prior transurethral resection of the bladder tumor

• Functioning bladder

PATIENT CHARACTERISTICS:

Age:

• Adult

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 10 g/dL

• White blood cell (WBC) count of at least 4,000/mm^3

• Absolute neutrophil count at least 1,800/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

Renal:

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

Other:

• No other prior or concurrent malignancy within the past 5 years except curatively treated nonmelanoma skin cancer, stage I prostate cancer, or carcinoma in situ of the cervix

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• Medically operable

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior pelvic radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No concurrent potential nephrotoxic or ototoxic drugs (e.g., aminoglycosides)