Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00693719|
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : August 21, 2013
Last Update Posted : November 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Etoposide Drug: Irinotecan hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study: Irinotecan and Etoposide as Treatment for Refractory, Metastatic Breast Cancer|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||May 2013|
Experimental: Etoposide and Irinotecan hydrochloride
Irinotecan 100 mg/m2 IV days 1 and 15. Etoposide 50 mg PO x14 days followed by 2 weeks off.
50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
Other Name: VepesidDrug: Irinotecan hydrochloride
Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle
Other Name: Irinotecan hydrochloride trihydrate
- 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 ]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 ]Still alive for a certain period of time after they were diagnosed with or started treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|