Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006485
Status:
COMPLETED
Last Update Posted:
2009-12-15
First Post:
2000-11-06
Brief Title:
Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Labeled Non-Randomized Phase I Study Of Flavopiridol Administered With Irinotecan CPT-11 In Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2003-06
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 Phase I trial to study the effectiveness of combining flavopiridol with irinotecan in treating patients who have locally advanced or metastatic solid tumors
PURPOSE Phase I trial to study the effectiveness of combining flavopiridol with irinotecan in treating patients who have locally advanced or metastatic solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of flavopiridol when combined with irinotecan in patients with advanced solid tumors
Determine the clinical pharmacokinetics of this regimen as well as the plasma levels of the active metabolite SN-38 and metabolic product SN-38 glucuronide in these patients
Determine in a preliminary manner the therapeutic activity of this regimen in these patients
Determine the role of p21 relative to treatment response and apoptosis in these patients treated with this regimen
OUTLINE This is a dose-escalation open-label non-randomized study of flavopiridol
Patients receive irinotecan IV over 30 minutes followed 7 hours later by flavopiridol IV over 1 hour on days 1 8 15 and 22 Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity During the first week of the second course patients receive flavopiridol alone on day 1 and irinotecan alone on day 2
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more of 6 patients in the initial cohort experience dose limiting toxicity during the first course of treatment An additional 10 patients are treated at the MTD
PROJECTED ACCRUAL A total of 44-50 patients will be accrued for this study within 1 year
Determine the maximum tolerated dose of flavopiridol when combined with irinotecan in patients with advanced solid tumors
Determine the clinical pharmacokinetics of this regimen as well as the plasma levels of the active metabolite SN-38 and metabolic product SN-38 glucuronide in these patients
Determine in a preliminary manner the therapeutic activity of this regimen in these patients
Determine the role of p21 relative to treatment response and apoptosis in these patients treated with this regimen
OUTLINE This is a dose-escalation open-label non-randomized study of flavopiridol
Patients receive irinotecan IV over 30 minutes followed 7 hours later by flavopiridol IV over 1 hour on days 1 8 15 and 22 Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity During the first week of the second course patients receive flavopiridol alone on day 1 and irinotecan alone on day 2
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more of 6 patients in the initial cohort experience dose limiting toxicity during the first course of treatment An additional 10 patients are treated at the MTD
PROJECTED ACCRUAL A total of 44-50 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2272 | None | None | None |
| MSKCC-00091 | None | None | None |