NCT00003930
Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
PHASE1
PHASE2
COMPLETED
NCT00003930
INTERVENTIONAL
A Phase I/II Trial in Patients With Muscle-Invading Bladder Cancer of Transurethral Surgery Plus Taxol, Cisplatin and Bid Irradiation Followed by Either Selective Bladder Preservation or Radical Cystectomy and Adjuvant Chemotherapy
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.
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)
Bladder Cancer
- TREATMENT
-
- Type: DRUG
- Name: cisplatin
- Description:
- Arm Group Labels: Arm 1
-
- Type: DRUG
- Name: gemcitabine hydrochloride
- Description:
- Arm Group Labels: Arm 1
-
- Type: DRUG
- Name: paclitaxel
- Description:
- Arm Group Labels: Arm 1
-
- Type: PROCEDURE
- Name: conventional surgery
- Description:
- Arm Group Labels: Arm 1
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels: Arm 1
- Radiation Therapy Oncology Group