Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
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: This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Fenretinide in Combination With Paclitaxel and Cisplatin|
- Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined. [ Time Frame: Courses (7 days) repeat every 21 days in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2000|
|Study Completion Date:||August 2006|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of the combination of fenretinide, paclitaxel, and cisplatin in patients with advanced solid tumors.
- Determine the effect of fenretinide on the pharmacokinetics of paclitaxel and cisplatin.
- Assess the relationship between dose or plasma levels of fenretinide and the safety and antitumor effects, in terms of overall response, response rate, and progression-free survival rate, in these patients.
OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin.
Patients receive oral fenretinide twice daily for 7 days. Patients receive paclitaxel IV over 3 hours and cisplatin IV over 30 minutes on day 7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin 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. Once the MTD is determined, additional patients are accrued to receive paclitaxel and cisplatin at the recommended phase II dose.
PROJECTED ACCRUAL: Approximately 15-24 patients will be accrued for this study within 12-24 months.
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Scot C. Remick, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|