Irinotecan and Temozolomide in Treating Patients With Breast Cancer Who Have Received Previous Treatment for Brain Metastases
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving irinotecan together with temozolomide and to see how well it works in treating patients with breast cancer who have received previous treatment for brain metastases.
Drug: irinotecan hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Irinotecan and Temozolomide in Breast Cancer Patients With Brian Metastases That Have Progressed After Stereotactic Radiosurgery or Whole Brain Radiation|
- Objective response rate (percentage of patients with complete or partial response) in the CNS at ≥ 16 weeks [ Time Frame: At least 16 weeks, up to one year ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Experimental: irinotecan and temozolomide||Drug: irinotecan hydrochloride Drug: temozolomide|
- To evaluate the objective response rate systemically and in the CNS to the combination of irinotecan hydrochloride and temozolomide among patients with breast cancer and progressive brain metastases that have progressed after previous treatment for brain metastases.
- To determine the toxicities associated with the combination of irinotecan hydrochloride and temozolomide in breast cancer patients with progressive brain metastases.
- To evaluate the time to first progression at any site (CNS or extra-CNS) in patients treated with the combination of irinotecan hydrochloride and temozolomide.
- To evaluate the overall survival of patients treated with the combination of irinotecan hydrochloride and temozolomide for brain metastases.
OUTLINE: Patients receive irinotecan IV on days 1 and 15 and oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617539
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Michelle Melisko, MD||University of California, San Francisco|