Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006037
Status:
TERMINATED
Last Update Posted:
2014-05-22
First Post:
2000-07-05
Brief Title:
Chemotherapy Plus IM-862 in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Phase II Randomized Placebo-Controlled Double-Blinded Study With 5-FU vs 5-FU With IM862 With Cross-Over to CPT-11 vs CPT-11 With IM862
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug not available
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 IM-862 may stop the growth of colorectal cancer by stopping blood flow to the tumor It is not yet known if chemotherapy is more effective with or without IM-862 in treating colorectal cancer
PURPOSE Randomized phase II trial to study the effectiveness of chemotherapy plus IM-862 in treating patients who have metastatic colorectal cancer
PURPOSE Randomized phase II trial to study the effectiveness of chemotherapy plus IM-862 in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Compare the efficacy of fluorouracil with or without IM-862 in terms of progression free survival in patients with previously untreated or recurrent metastatic adenocarcinoma of the colon or rectum II Determine the toxicity of IM-862 and fluorouracil in these patients III Determine the efficacy of IM-862 in combination with irinotecan in terms of progression free survival in patients who have disease progression after receiving fluorouracil IV Obtain preliminary data on molecular markers of response and time to progression by determining levels of genes involved in adhesion angiogenesis apoptosis and drug resistance prior to and during chemotherapy V Determine the molecular correlates for response and time to progression through analysis of serum and urine markers of angiogenesis such as vascular endothelial growth factor and fibroblast growth factor in patients treated with IM-862 in combination with fluorouracil or irinotecan VI Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized double blind placebo controlled crossover study Patients are randomized to one of two treatment arms Arm I Patients receive fluorouracil IV continuously on days 1-21 and IM-862 intranasally three times daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression Patients who develop disease progression are taken off fluorouracil and IM-862 and then receive irinotecan IV over 90 minutes weekly for 4 weeks Courses repeat every 6 weeks in the absence of disease progression Arm II Patients receive fluorouracil as in arm I and placebo intranasally three times daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression Patients who develop disease progression are taken off fluorouracil and placebo and then receive irinotecan and IM-862 as in arm I on days 1-42 Courses repeat every 6 weeks in the absence of disease progression Quality of life is assessed prior to study and then prior to every course during study Patients are followed for a minimum of 6 months
PROJECTED ACCRUAL A total of 66 patients 33 per arm will be accrued for this study within 26-27 months
OUTLINE This is a randomized double blind placebo controlled crossover study Patients are randomized to one of two treatment arms Arm I Patients receive fluorouracil IV continuously on days 1-21 and IM-862 intranasally three times daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression Patients who develop disease progression are taken off fluorouracil and IM-862 and then receive irinotecan IV over 90 minutes weekly for 4 weeks Courses repeat every 6 weeks in the absence of disease progression Arm II Patients receive fluorouracil as in arm I and placebo intranasally three times daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression Patients who develop disease progression are taken off fluorouracil and placebo and then receive irinotecan and IM-862 as in arm I on days 1-42 Courses repeat every 6 weeks in the absence of disease progression Quality of life is assessed prior to study and then prior to every course during study Patients are followed for a minimum of 6 months
PROJECTED ACCRUAL A total of 66 patients 33 per arm will be accrued for this study within 26-27 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-G00-1812 | None | None | None |
| LAC-USC-3C993 | None | None | None |