Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function

Inclusion Criteria:

• Histologically or cytologically confirmed transitional cell carcinoma (TCC) of thebladder, urethra, or upper urinary tract

• Mixed TCC and variant histologies (i.e., small cell, squamous cell, adenocarcinoma, orsarcoma) allowed if present in < 50% of the biopsy specimen

• Patients must sign an informed consent indicating that they are aware of theinvestigational nature of this study, in keeping with the policies of the institution.

• Measurable disease: may include radiographic detection of metastases in lymph nodes (>= 1.5 cm) or liver or lung (>= 1.0 cm) OR pelvic mass palpable on examination underanesthesia

• Creatinine clearance < 60 mL/min; no renal insufficiency that requires hemodialysis;no renal insufficiency that is reversible in patients with tumor confined to theprimary site (i.e., that is potentially resectable with neoadjuvant chemotherapy)

• Zubrod performance status 0-2

• Platelet count > 100,000/mm^3

• Absolute granulocyte count > 1,500/mm^3

• Bilirubin =< 2.0 mg/dL

• Aminotransferases (AST and ALT) =< 2 times upper limit of normal

• Left ventricular ejection fraction (LVEF) > 40% OR normal electrocardiogram (EKG orECG) and no history of cardiac disease

• All patients must be evaluated in the Department of Genitourinary Medical Oncology atM. D. Anderson Cancer Center or participating CCOP center prior to signing informedconsent.

• No prior systemic chemotherapy including, adjuvant or neoadjuvant therapy

• Prior intravesicular chemotherapy allowed

Exclusion Criteria:

• No brain metastases

• Not pregnant or nursing

• No severe or uncontrolled infection

• No New York Heart Association class III-IV congestive heart failure, unstable angina,or history of myocardial infarction within the past 6 months

• No peripheral neuropathy >= grade 2

• No persistently uncontrolled diabetes mellitus

• No chronic liver disease

• No HIV positivity

• No other malignancy except nonmelanoma skin cancer unless disease-free for the past 3years

• No overt psychosis, mental disability, or other condition that would preclude givinginformed consent

• No known sickle cell disease

• No uncontrolled severe hypertension

• Renal insufficiency that requires hemodialysis or renal insufficiency that isreversible in patients with tumor confined to the primary site (i.e., that ispotentially resectable with neoadjuvant chemotherapy).