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

• Status: Completed
• Trial end date: 2009-12-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable objective response rate, time to disease progression and survival were also assessed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leonard Appleman; University of Pittsburgh
• Collaborator: Sanofi-Synthelabo
• Treatments: Docetaxel; Oxaliplatin

Criteria

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 < 18 years of age, they are excluded from this study.

• Life expectancy of greater than 6 months.

• ECOG Performance status of 0-1.

• Must have received prior treatment with standard of care chemotherapy No more than 2 prior regimens of cytotoxic chemotherapy.

• No other experimental treatment, cytotoxics or radiation 4 weeks prior to enrollment.

• Patients must have acceptable organ function as defined below:

Hematopoietic: WBC > 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.