Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275041
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2006-01-10
Brief Title:
Irinotecan and Cetuximab in Treating Patients With Metastatic Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Concurrent Irinotecan Plus Cetuximab in Patients With Advanced Breast Cancer With Prior Anthracycline andor Taxane-Containing Therapy
Status:
COMPLETED
Status Verified Date:
2016-12
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 such as irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Giving irinotecan together with cetuximab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving irinotecan together with cetuximab works in treating patients with metastatic breast cancer
PURPOSE This phase II trial is studying how well giving irinotecan together with cetuximab works in treating patients with metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity by confirmed response rate of concurrent irinotecan hydrochloride and cetuximab in patients with metastatic breast cancer with prior anthracycline andor taxane-containing therapy
Secondary
Estimate 6-month progression-free survival of patients
Evaluate the adverse event profile of irinotecan hydrochloride in combination with cetuximab in patients with metastatic breast cancer
Estimate progression-free survival of patients
Estimate overall survival
OUTLINE Patients receive cetuximab IV over 1-2 hours on days 1 8 and 15 and irinotecan hydrochloride IV over 1½ hours on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 38 patients will be accrued for this study
Primary
Determine the antitumor activity by confirmed response rate of concurrent irinotecan hydrochloride and cetuximab in patients with metastatic breast cancer with prior anthracycline andor taxane-containing therapy
Secondary
Estimate 6-month progression-free survival of patients
Evaluate the adverse event profile of irinotecan hydrochloride in combination with cetuximab in patients with metastatic breast cancer
Estimate progression-free survival of patients
Estimate overall survival
OUTLINE Patients receive cetuximab IV over 1-2 hours on days 1 8 and 15 and irinotecan hydrochloride IV over 1½ hours on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 38 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-2012-02679 | REGISTRY | None | None |
| CDR0000456255 | REGISTRY | PDQ Physician Data Query | None |