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|
- Median Time to Progression [ Time Frame: Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months ] [ Designated as safety issue: No ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Overall Survival [ Time Frame: Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 months ] [ Designated as safety issue: No ]Still alive for a certain period of time after they were diagnosed with or started treatment
|Study Start Date:||August 2007|
|Study Completion Date:||May 2013|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693719
|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|