Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007917
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2001-01-06
Brief Title:
Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial Of Gemcitabine Followed By Flavopiridol In Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-02
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 gemcitabine plus flavopiridol 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 gemcitabine and flavopiridol in patients with advanced solid tumors
II Determine the toxicity and safety profile of this regimen in these patients
III Determine the pharmacokinetic profile of this regimen in this patient population
OUTLINE This is a dose-escalation study
Patients receive gemcitabine IV over 1-25 hours on days 1 and 8 and flavopiridol IV continuously over 24 hours on days 2 and 9 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the maximum tolerated dose MTD is reached 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 Approximately 6-58 patients will be accrued for this study
I Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with advanced solid tumors
II Determine the toxicity and safety profile of this regimen in these patients
III Determine the pharmacokinetic profile of this regimen in this patient population
OUTLINE This is a dose-escalation study
Patients receive gemcitabine IV over 1-25 hours on days 1 and 8 and flavopiridol IV continuously over 24 hours on days 2 and 9 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the maximum tolerated dose MTD is reached 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 Approximately 6-58 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000068344 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchP30CA006516 |
| U01CA062490 | NIH | None | None |
| P30CA006516 | NIH | None | None |
| DFCI-00166 | None | None | None |
| NCI-24 | None | None | None |