Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer

Inclusion Criteria:

- Histologic diagnosis of urothelial carcinoma (TCC or Squamous) that is either
metastatic or locally recurrent and not curable by surgery or radiation therapy.

- All patients must have tissue from either the primary or metastatic site tested for
HER2 status determination. Patients with Her-2 negative tumors are not eligible for
treatment on this protocol.

- All patients must have a blood sample drawn for HER2 serologic testing.

- If the available tissue is from the primary tumor and is HER2 negative and if the
serum is negative, to qualify for the study a biopsy of a metastatic site should be
done and the patient will be eligible ONLY if this demonstrates HER2 over-expression.

- Patients may not have received prior systemic chemotherapy for metastatic disease.
Patients may have received adjuvant chemotherapy if completed at least 6 months prior
to beginning this protocol treatment.

- Patients may not have cardiac disease and must have adequate cardiac function
(ejection fraction > 50% or higher than the lower limit of institutional normal) as
determined by a MUGA scan or 2-D echocardiogram within 4 weeks from registration, and
no evidence of symptomatic coronary artery disease (baseline EKG must show no active
ischemia). Patients must not have history of congestive heart failure.

- If patients have received prior radiation therapy, disease must be present outside of
radiated fields and at least 4 weeks must have elapsed since discontinuation of that
therapy.

Exclusion Criteria:

- Pregnant or lactating women may not participate.

- HIV – positive patients may not participate. This is to avoid additional
complications that immune suppression and HIV infection may cause due to the intense
nature of the chemotherapy in this trial.