Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan and etoposide, 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 how well giving irinotecan together with etoposide works in treating patients with recurrent, locally advanced, or metastatic breast cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE II STUDY: IRINOTECAN AND ETOPOSIDE AS TREATMENT FOR REFRACTORY, METASTATIC BREAST CANCER|
- Clinical response (complete and partial response) rate as assessed by RECIST criteria [ Time Frame: Every eight weeks ] [ Designated as safety issue: No ]
- Response duration [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Every 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
50 mg PO x14 days followed by 2 weeks off, 28 day/CycleDrug: Irinotecan hydrochloride
Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
- To determine the response rate, as assessed by RECIST criteria, in patients with recurrent locally advanced or metastatic breast cancer treated with irinotecan hydrochloride and etoposide after prior exposure to anthracycline, taxane, and capecitabine therapy.
- To determine the median time to progression in these patients.
- To determine the response duration and survival in these patients.
- To measure the type and rate of grade 3 or greater toxicity of this treatment regimen in these patients.
OUTLINE: Patients receive irinotecan hydrochloride IV on days 1 and 15 and oral etoposide on days 1-14. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
After completion of study therapy, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
|United States, Arizona|
|Arizona Cancer Center at University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724-5024|
|Principal Investigator:||Robert B. Livingston, MD||University of Arizona|