Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009932
Status:
UNKNOWN
Last Update Posted:
2013-05-15
First Post:
2001-02-02
Brief Title:
Combination Chemotherapy in Treating Patients With Solid Tumors
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2002-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 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
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
Detailed Description:
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
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
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 |
|---|---|---|---|
| NCI-2530 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068425 | REGISTRY | None | None |