S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms
Intervention: carboplatin; gemcitabine; paclitaxel; surgery
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anterior urethral cancer; localized transitional cell cancer of the renal pelvis and ureter; posterior urethral cancer; stage II bladder cancer; stage III bladder cancer; transitional cell carcinoma of the bladder; urethral cancer associated with invasive bladder cancer; regional transitional cell cancer of the renal pelvis and ureter

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells and decrease
      the need for surgery.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      observation or surgery to remove the bladder (cystectomy) in treating patients who have stage
      II or stage III cancer of the urothelium.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial
             transitional cell cancer (TCC) of the bladder

          -  Focal squamous and/or adenocarcinoma differentiation, defined as ≤ 10% of tumor volume
             allowed

          -  The following diagnoses are not allowed:

               -  Small cell carcinoma

               -  Sarcomatoid components

          -  Disease diagnosed with an initial transurethral resection of bladder tumor (TURBT) and
             a second TURBT performed within 8 weeks of first with attempt to remove all tumor
             present

               -  Residual disease after second TURBT allowed

               -  No more than 14-56 days after second TURBT

          -  No metastatic disease by chest x-ray and CT scan or MRI of the abdomen and pelvis

          -  Fresh tumor tissue, paraffin tumor tissue, unstained slides, or cell block specimen
             from one or both TURBTs available

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  White blood cell count (WBC) at least 3,500/mm^3

          -  Absolute granulocyte count at least 1,500/mm^3

          -  Platelet count at least lower limit of normal

        Hepatic

          -  Bilirubin no greater than 1.5 mg/dL

          -  Aspartate aminotransferase (SGOT) no greater than 2 times upper limit of normal

        Renal

          -  Creatinine no greater than 2.0 mg/dL AND/OR

          -  Creatinine clearance at least 60 mL/min

        Other

          -  No prohibitive medical risk that would preclude radical cystectomy

          -  No other serious concurrent systemic disorder that would preclude study compliance

          -  No other malignancy except adequately treated basal cell or squamous cell skin cancer,
             carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete
             remission, or any other cancer for which patient has been disease-free for 5 years

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Prior intravesical immunotherapy allowed

        Chemotherapy

          -  No prior systemic chemotherapy for TCC of the urothelium

          -  Prior intravesical chemotherapy allowed

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy for TCC of the urothelium

          -  No concurrent radiotherapy

        Surgery

          -  See Disease Characteristics