Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy
RATIONALE: Drugs used in chemotherapy such as edotecarin use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well edotecarin works in treating women with locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer|
|Study Start Date:||June 2003|
|Study Completion Date:||December 2009|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of edotecarin in women with anthracycline- and taxane-refractory or chemoresistant locally advanced or metastatic breast cancer.
- Determine the time to tumor response and duration of response in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the clinical benefit of this drug in these patients.
- Determine the safety and tolerability of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive edotecarin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months until disease progression.
PROJECTED ACCRUAL: A total of 31-65 patients will be accrued for this study.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Andrew D. Seidman, MD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||Clifford A. Hudis, MD||Memorial Sloan-Kettering Cancer Center|