Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy
- Conditions
- Breast Cancer
- Registration Number
- NCT00070031
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* Determine the antitumor activity of edotecarin in women with anthracycline- and taxane-refractory or chemoresistant locally advanced or metastatic breast cancer.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States