A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors
- Determine the maximum tolerated dose, clinical toxicity, and recommended phase II dose
of fenretinide when combined with paclitaxel and cisplatin in patients with refractory
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the therapeutic response to this regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study of fenretinide.
Patients receive oral fenretinide twice daily on days 1-7 and paclitaxel IV over 3 hours
followed by cisplatin IV over 2 hours on day 2. On day 8 of course 1, patients also receive
fenretinide once in the morning. Treatment repeats every 3 weeks for a maximum of 8 courses
in the absence of disease progression or unacceptable toxicity. Patients who achieve
complete response receive 2 additional courses.
Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
Gregory A. Otterson, MD
Ohio State University Comprehensive Cancer Center
United States: Federal Government
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|