Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016185
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2001-05-06
Brief Title:
Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase I Study Of Flavopiridol And Docetaxel Taxotere In Patients With Advanced Cancers
Status:
COMPLETED
Status Verified Date:
2013-04
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 and docetaxel in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining flavopiridol and docetaxel in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the dose-limiting toxic effects and maximum tolerated dose of flavopiridol and docetaxel in patients with advanced solid tumors
Determine the objective response rate and duration of response in patients treated with this regimen
Determine the pharmacokinetics of these drugs in this patient population
OUTLINE This is a dose-escalation study
Patients receive docetaxel IV over 60 minutes on day 1 and flavopiridol IV continuously over 24 hours on day 2 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel and flavopiridol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study within 9-11 months
Determine the dose-limiting toxic effects and maximum tolerated dose of flavopiridol and docetaxel in patients with advanced solid tumors
Determine the objective response rate and duration of response in patients treated with this regimen
Determine the pharmacokinetics of these drugs in this patient population
OUTLINE This is a dose-escalation study
Patients receive docetaxel IV over 60 minutes on day 1 and flavopiridol IV continuously over 24 hours on day 2 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel and flavopiridol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study within 9-11 months
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-1610 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-C-2197 | None | None | None |