Irinotecan and Cetuximab in Treating Patients With Metastatic Breast Cancer
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.
Drug: irinotecan hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Concurrent Irinotecan Plus Cetuximab in Patients With Advanced Breast Cancer With Prior Anthracycline and/or Taxane-Containing Therapy|
- Confirmed tumor response (complete or partial) [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Progression-free survival at 6 months [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity, by confirmed response rate, of concurrent irinotecan hydrochloride and cetuximab in patients with metastatic breast cancer with prior anthracycline and/or taxane-containing therapy.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275041
|Study Chair:||Timothy Hobday, MD||Mayo Clinic|
|Investigator:||Edith A. Perez, MD||Mayo Clinic|
|Investigator:||Matthew P. Goetz, MD||Mayo Clinic|