Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079352
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2004-03-08
Brief Title:
Flavopiridol Gemcitabine and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase I trial is studying the side effects and best dose of flavopiridol when given together with gemcitabine and irinotecan in treating patients with unresectable or metastatic solid tumors Drugs used in chemotherapy such as flavopiridol gemcitabine and irinotecan work in 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:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and recommended phase II dose of flavopiridol in combination with gemcitabine and irinotecan in patients with unresectable or metastatic solid tumors
II Determine the toxicity profile of this regimen in these patients
OUTLINE This is a dose-escalation study of flavopiridol
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 15 Patients also receive flavopiridol IV over 60 minutes on days 2 and 16 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity 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 of 3 or 2 of 6 patients experience dose-limiting toxicity
I Determine the maximum tolerated dose and recommended phase II dose of flavopiridol in combination with gemcitabine and irinotecan in patients with unresectable or metastatic solid tumors
II Determine the toxicity profile of this regimen in these patients
OUTLINE This is a dose-escalation study of flavopiridol
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 15 Patients also receive flavopiridol IV over 60 minutes on days 2 and 16 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity 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 of 3 or 2 of 6 patients experience dose-limiting toxicity
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 |
|---|---|---|---|
| UNM-0903C | None | None | None |
| CDR0000355358 | REGISTRY | PDQ Physician Data Query | None |