| Exclusion Criteria: | 1) Patients with known or clinical suspicion of brain metastases.
2) Renal insufficiency that requires hemodialysis.
3) Renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy).
4) Prior systemic gemcitabine, paclitaxel, doxorubicin, or any systemic chemotherapy for metastatic transitional cell carcinoma. Any prior intravesicular chemotherapy is allowed. Patients with prior systemic chemotherapy are eligible only if no gemcitabine, paclitaxel, doxorubicin, or mitoxantrone was given, and the treatment was completed at least 3 years before protocol entry in the case of second malignancies, or 1 year before protocol entry in the case of adjuvant or neoadjuvant chemotherapy for locally advanced urothelial carcinoma.
5) Patients with severe or uncontrolled intercurrent infection.
6) Patients with NYHA Class III/IV congestive heart failure, unstable angina, or history of myocardial infarction within the last 6 months.
7) Peripheral neuropathy, grade 2 or worse.
8) Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus, chronic liver disease or HIV infection.
9) Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
10) Overt psychosis, mental disability, or otherwise incompetent to give informed consent.
11) Women who are pregnant, likely to become pregnant, or lactating are excluded.
12) Patients known to have sickle cell disease. |