Phase II Study for the Evaluation of CPT-11 (Irinotecan, Camptosar) in Patients With Metastatic or Recurrent Breast Cancer
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.
Interventional
Primary Purpose: Treatment
William J. Gradishar, MD
Study Chair
Robert H. Lurie Cancer Center
United States: Federal Government
NU 98B3
NCT00004182
October 1999
April 2000
Name | Location |
---|---|
Stanford University Medical Center | Stanford, California 94305-5408 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |