A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed primary transitional cell carcinoma (TCC)
of the bladder

- Histologic evidence of muscularis propria invasion

- Meets 1 of the following stage criteria:

- Stage T2-4a; NX, N0, or N1; and M0 disease

- Clinical stage T1, grade 3/3 disease AND requires definitive local therapy

- Tumor involvement of the prostatic urethra allowed provided the following criteria
are met:

- Tumor was visibly completely resected

- No evidence of stromal invasion of the prostate

- No evidence of distant metastases by chest x-ray (or chest CT scan) within 8
weeks prior to registration

- No evidence of distant metastases by abdominal/pelvic CT scan (or MRI scan)
within 8 weeks prior to registration

- Has undergone transurethral bladder resection (as thorough as is judged safely
possible) within the past 3-8 weeks, including bimanual examination with tumor
mapping

- Sufficient tumor tissue available for HER2/neu analysis

- Not a candidate for radical cystectomy

- Performance status - Zubrod 0-2

- Absolute neutrophil count >= 1,800/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin >= 8.0 g/dL (transfusion or other intervention allowed)

- Bilirubin < 2.0 mg/dL

- SGOT and SGPT < 2.5 times upper limit of normal

- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Creatinine =< 3.0 mg/dL

- LVEF >= 40% by MUGA scan or echocardiogram

- No unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- No transmural myocardial infarction within the past 6 months

- Not pregnant or nursing

- No nursing for 6 months after completion of study treatment (for patients receiving
trastuzumab [Herceptin®])

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- Able to tolerate systemic chemotherapy and pelvic radiotherapy

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

- No history of allergic reaction to study drugs

- No history of inflammatory bowel disease

- No acute bacterial or fungal infection requiring IV antibiotics

- No AIDS

- No other severe active comorbidity

- No prior systemic chemotherapy with anthracyclines or taxanes

- No prior systemic chemotherapy for TCC

- No prior pelvic radiotherapy