Irinotecan in Treating Patients With Metastatic or Recurrent Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study for the Evaluation of CPT-11 (Irinotecan, Camptosar) in Patients With Metastatic or Recurrent Breast Cancer|
|Study Start Date:||October 1999|
|Study Completion Date:||April 2000|
|Primary Completion Date:||April 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the objective response rate to irinotecan in patients with metastatic breast cancer who have received prior anthracycline and taxane based chemotherapy for metastatic disease. II. Determine the toxicities of irinotecan in these patients. III. Determine survival time, duration of response, and time to treatment failure in these patients after this therapy.
OUTLINE: Patients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at day 30, then every 3 months.
PROJECTED ACCRUAL: A total of 14-29 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004182
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305-5408|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|Study Chair:||William J. Gradishar, MD||Robert H. Lurie Cancer Center|