S0121, Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed primary or recurrent invasive carcinoma of the urothelium
• •* Transitional, squamous, or mixed cell subtypes allowed
• •* Primary disease site must be the urinary bladder or urethra
• •* Disease confined to the true pelvis (T2-T4, N0-N3, M0)
• •* Must meet at least 1 of the following criteria:
• •* Nodal involvement at or below the level of the bifurcation of the iliac vessels
• •* Medically or surgically inoperable
• •* Patient refused cystectomy
• •Measurable or nonmeasurable disease
• •Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed bladder mapping within the past 56 days
• •No extrapelvic metastases
• •Eligible to receive radiotherapy
• •* Planned radiotherapy at a SWOG-approved facility
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Zubrod 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Granulocyte count at least 1,500/mm\^3
• •Platelet count at least lower limit of normal
• •Hepatic
• •Bilirubin no greater than upper limit of normal (ULN)
• •SGOT or SGPT no greater than 2.5 times ULN
• •Renal
• •Creatinine clearance at least 60 mL/min OR
• •Creatinine no greater than ULN
• •Gastrointestinal
• •No chronic diarrhea
• •No malabsorption
• •No extensive diverticular disease of the colon
• •No inflammatory bowel disease
• •No other pre-existing gastrointestinal disorders
• •Other
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •No active infections requiring antibiotics
• •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •No prior chemotherapy for patients with a current diagnosis of advanced bladder cancer that is also the initial diagnosis
• •No prior systemic chemotherapy except adjuvant therapy for recurrent disease completed more than 6 months ago
• •No prior carboplatin
• •No prior paclitaxel
• •No prior gemcitabine
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •See Disease Characteristics
• •No prior pelvic radiotherapy
• •Surgery
• •See Disease Characteristics
• •Recovered from prior surgery