Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049296
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2002-11-12
Brief Title:
Thalidomide and Docetaxel in Treating Patients With Advanced Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel A Regimen Based on Anti-Angiogenic Therapeutic Principles
Status:
COMPLETED
Status Verified Date:
2010-06
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 Thalidomide may stop the growth of cancer by stopping blood flow to the tumor Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining thalidomide with docetaxel may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining thalidomide with docetaxel in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of combining thalidomide with docetaxel in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors multiple myeloma and non-Hodgkins lymphoma
Determine the dose-limiting toxicity and safety profile of this regimen in these patients
Determine the plasma pharmacokinetics of this regimen in these patients
Determine the objective tumor response and prolonged freedom from progression in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive oral thalidomide twice daily and docetaxel IV over 30 minutes once weekly Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 3-30 patients will be accrued for this study
Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors multiple myeloma and non-Hodgkins lymphoma
Determine the dose-limiting toxicity and safety profile of this regimen in these patients
Determine the plasma pharmacokinetics of this regimen in these patients
Determine the objective tumor response and prolonged freedom from progression in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive oral thalidomide twice daily and docetaxel IV over 30 minutes once weekly Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 3-30 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 |
|---|---|---|---|
| NCI-G02-2123 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-4Y01 | None | None | None |