Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003995
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Plus Chemotherapy in Treating Patients With Advanced Colorectal Cancer That Overexpresses HER2
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II and Pharmacokinetic Study of CPT-11 and Trastuzumab RhuMab HER2 Herceptin in Advanced Colo-Rectal Cancer With p185 HER 2 Overexpression
Status:
COMPLETED
Status Verified Date:
2007-06
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:
Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab and chemotherapy with irinotecan in treating patients who have stage IV colorectal cancer that overexpresses HER2 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the objective response rate of irinotecan and trastuzumab in patients with stage IV colorectal cancer and p185 HER2 overexpression
II Evaluate the safety and toxic effects of this treatment regimen in these patients
III Determine the overall survival and time to progression in these patients in response to this treatment regimen
IV Determine the pharmacokinetics of trastuzumab in combination with irinotecan and antibodies to trastuzumab in these patients
V Determine the expression of HER2neu in these patients
OUTLINE This is a multicenter study
Patients receive a loading dose of trastuzumab IV over 90 minutes on week 1 and over 30-90 minutes weekly thereafter Patients receive irinotecan IV over 90 minutes following trastuzumab weekly for 4 weeks Courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
I Determine the objective response rate of irinotecan and trastuzumab in patients with stage IV colorectal cancer and p185 HER2 overexpression
II Evaluate the safety and toxic effects of this treatment regimen in these patients
III Determine the overall survival and time to progression in these patients in response to this treatment regimen
IV Determine the pharmacokinetics of trastuzumab in combination with irinotecan and antibodies to trastuzumab in these patients
V Determine the expression of HER2neu in these patients
OUTLINE This is a multicenter study
Patients receive a loading dose of trastuzumab IV over 90 minutes on week 1 and over 30-90 minutes weekly thereafter Patients receive irinotecan IV over 90 minutes following trastuzumab weekly for 4 weeks Courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 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 |
|---|---|---|---|
| PCI-98-056 | None | None | None |
| NCI-T98-0078 | None | None | None |
| CDR0000067205 | REGISTRY | PDQ Physician Data Query | None |