Combination Chemotherapy in Treating Patients With Solid Tumors
Recruitment status was: Active, not recruiting
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining fenretinide, paclitaxel, and cisplatin in treating patients who have solid tumors that have not responded to previous therapy.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: cisplatin Drug: fenretinide Drug: paclitaxel||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors|
|Study Start Date:||January 2001|
- Determine the maximum tolerated dose, clinical toxicity, and recommended phase II dose of fenretinide when combined with paclitaxel and cisplatin in patients with refractory solid tumors.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009932
|United States, Ohio|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Gregory A. Otterson, MD||Ohio State University Comprehensive Cancer Center|