Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072436
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2003-11-04
Brief Title:
Gemcitabine Hydrochloride and Alvocidib in Treating Patients With Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Gemcitabine Followed by a Short Infusion of Flavopiridol in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-07
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 gemcitabine hydrochloride and alvocidib in treating patients with solid tumors Drugs used in chemotherapy such as gemcitabine hydrochloride and alvocidib 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:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with solid tumors
SECONDARY OBJECTIVES
I Determine the safety profile and toxic effects of this regimen in these patients
II Determine the pharmacokinetics of flavopiridol with and without gemcitabine in these patients
III Determine using pharmacodynamic assays the activity of flavopiridol as a cdk inhibitor in these patients
IV Determine using pharmacodynamic assays the markers of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Some patients receive an initial dose of alvocidib IV over 1-7 hours on day 1 course 0 Beginning 1 week later and for all subsequent courses all patients receive gemcitabine hydrochloride IV over 60-150 minutes on days 1 and 15 and alvocidib IV over 1-7 hours on days 2 and 16 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and alvocidib 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 up to 10 additional patients receive treatment at that dose
Patients are followed at 30 days after study completion
I Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with solid tumors
SECONDARY OBJECTIVES
I Determine the safety profile and toxic effects of this regimen in these patients
II Determine the pharmacokinetics of flavopiridol with and without gemcitabine in these patients
III Determine using pharmacodynamic assays the activity of flavopiridol as a cdk inhibitor in these patients
IV Determine using pharmacodynamic assays the markers of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study
Some patients receive an initial dose of alvocidib IV over 1-7 hours on day 1 course 0 Beginning 1 week later and for all subsequent courses all patients receive gemcitabine hydrochloride IV over 60-150 minutes on days 1 and 15 and alvocidib IV over 1-7 hours on days 2 and 16 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and alvocidib 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 up to 10 additional patients receive treatment at that dose
Patients are followed at 30 days after study completion
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 |
|---|---|---|---|
| CDR0000339727 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062490 |
| 6051 | None | None | None |
| P30CA006516 | NIH | None | None |
| U01CA062490 | NIH | None | None |