Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045448
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2002-09-06
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2009-12
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 with docetaxel in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining flavopiridol with docetaxel in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of flavopiridol when administered in combination with 2 different doses of docetaxel in patients with advanced solid tumors
Determine the clinical pharmacokinetics of this regimen in these patients
Determine preliminarily the therapeutic activity of this regimen in these patients
OUTLINE This is a dose-escalation study of flavopiridol
Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by flavopiridol IV over 1 hour on days 1 8 and 15 Courses repeat every 4 weeks 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 at least 2 of 6 patients experience dose-limiting toxicity Separate MTDs of flavopiridol are determined when flavopiridol is combined with 2 different doses of docetaxel A total of 10 patients are treated at each flavopiridol MTD
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 6-56 patients will be accrued for this study
Determine the maximum tolerated dose of flavopiridol when administered in combination with 2 different doses of docetaxel in patients with advanced solid tumors
Determine the clinical pharmacokinetics of this regimen in these patients
Determine preliminarily the therapeutic activity of this regimen in these patients
OUTLINE This is a dose-escalation study of flavopiridol
Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by flavopiridol IV over 1 hour on days 1 8 and 15 Courses repeat every 4 weeks 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 at least 2 of 6 patients experience dose-limiting toxicity Separate MTDs of flavopiridol are determined when flavopiridol is combined with 2 different doses of docetaxel A total of 10 patients are treated at each flavopiridol MTD
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 6-56 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-02034 | None | None | None |
| NCI-G02-2106 | None | None | None |
| CDR0000256563 | REGISTRY | PDQ Physician Data Query | None |