Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062127
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2003-06-05
Brief Title:
Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Pharmacokinetic Interaction Study of Irinotecan NSC616348 and Thalidomide NSC66847 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Thalidomide may stop the growth of cancer by stopping blood flow to the tumor Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die Combining thalidomide with irinotecan may kill more tumor cells This randomized phase I trial is studying the side effects and best way to give irinotecan and thalidomide in treating patients with metastatic or unresectable solid tumors
Detailed Description:
PRIMARY OBJECTIVES
I Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors
II Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients
III Determine the toxicity of this regimen in these patients IV Determine the observed antitumor response in patients treated with this regimen
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28
Arm II Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7
All patients undergo disease re-evaluation at 6 weeks Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
I Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors
II Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients
III Determine the toxicity of this regimen in these patients IV Determine the observed antitumor response in patients treated with this regimen
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28
Arm II Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7
All patients undergo disease re-evaluation at 6 weeks Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 35 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 |
|---|---|---|---|
| CDR0000304517 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA069852 |
| 12044B | None | None | None |
| U01CA069852 | NIH | None | None |