Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005819
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Trial of Fenretinide in Combination With Paclitaxel and Cisplatin
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASE-3Y99 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| U01CA062502 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-3Y99 | OTHER | None | None |
| NCI-T99-0098 | None | None | None |