Combination Chemotherapy in Treating Patients With Solid Tumors
A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors
Sponsor: National Cancer Institute (NCI)
Listed as NCT00009932, this PHASE1 trial focuses on Unspecified Adult Solid Tumor, Protocol Specific and remains ongoing. Sponsored by National Cancer Institute (NCI), it has been updated 5 times since 2001, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)OBJECTIVES:
* 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.
OBJECTIVES:
* 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.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Unknown PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE1
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE1
-
Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE1
-
Jan 2017 — Jun 2018 [monthly]
Unknown Status PHASE1
First recorded
Jan 2001
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Cancer Institute (NCI)
- Ohio State University Comprehensive Cancer Center
For direct contact, visit the study record on ClinicalTrials.gov .