Study of Docetaxel and Oxaliplatin in Metastatic Transitional Cell Cancer (TCC) of the Urothelial Tract

Inclusion Criteria

• Patients must have histologically or cytologically confirmed transitional cell carcinoma of the Urothelial tract.
• Confirmed metastatic disease.
• Measurable progressive disease is required.
• 18 years of age. Because no dosing or adverse event data are currently available on the use of oxaliplatin in patients 2500/mm3 or ANC > 1500/mm3, hemoglobin > 9.0 g/dL, platelet count > 100,000/mm3 Hepatic: Bilirubin < 1.5 mg/dL, SGOT/SGPT < 2 x ULN (< 4 x ULN if liver metastases present) Renal: Creatinine < 1.8 mg/dL
• Adequate neurologic function defined as no clinically significant peripheral neuropathy, defined as any neuropathy ≤ grade 1.
• Adequate cardiovascular function defined as no active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months.

Exclusion Criteria

• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• No prior therapy with oxaliplatin is allowed.
• No history of allergic reactions attributed to the drugs used in this study or compounds of similar chemical or biologic composition.
• No history of intolerance or allergy to the antiemetics to be administered in conjunction with the study drugs (i.e., 5 HT3 antagonists).
• No concurrent other active cancer from another primary site, except squamous cell and basal cell carcinoma of the skin.
• No other serious concomitant illness will be allowed, including interstitial pneumonia, extensive and symptomatic fibrosis of the lung, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, NYHA Class III or IV, serious cardiac arrhythmia, uncontrolled diabetes mellitus or active infection.