A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates

Inclusion 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