Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046917
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2002-10-03
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Labeled Non-Randomized Phase I Study of Alvocidib Flavopiridol Administered With Irinotecan CPT-11 and Cisplatin in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2011-10
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:
Phase I trial to study the effectiveness of combining alvocidib irinotecan hydrochloride and cisplatin in treating patients who have advanced solid tumors 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
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of flavopiridol alvocidib irinotecan irinotecan hydrochloride and cisplatin in patients with advanced solid tumors
II Determine the clinical pharmacokinetics of this regimen in these patients III Determine preliminarily the therapeutic activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients are stratified according to the number of prior treatment regimens 0 or 1 vs more than 1 Patients receive irinotecan hydrochloride intravenously IV over 30 minutes followed immediately by cisplatin IV over 30 minutes followed 7 hours later by alvocidib IV over 1-45 hours weekly for 2 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of cisplatin alvocidib and irinotecan hydrochloride until the maximum tolerated dose MTD of each is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 12 additional patients are treated at the recommended phase II dose
I Determine the maximum tolerated dose of flavopiridol alvocidib irinotecan irinotecan hydrochloride and cisplatin in patients with advanced solid tumors
II Determine the clinical pharmacokinetics of this regimen in these patients III Determine preliminarily the therapeutic activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients are stratified according to the number of prior treatment regimens 0 or 1 vs more than 1 Patients receive irinotecan hydrochloride intravenously IV over 30 minutes followed immediately by cisplatin IV over 30 minutes followed 7 hours later by alvocidib IV over 1-45 hours weekly for 2 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of cisplatin alvocidib and irinotecan hydrochloride until the maximum tolerated dose MTD of each is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 12 additional patients are treated at the recommended phase II dose
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-2009-00023 | REGISTRY | None | None |
| NCI-5700 | None | None | None |
| CDR0000257034 | None | None | None |
| MSKCC-02043 | None | None | None |
| 02-043A | OTHER | None | None |
| 5700 | OTHER | None | None |
| P30CA008748 | NIH | None | None |
| R01CA067819 | NIH | None | None |
| U01CA069856 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069856 |