Breast Cancer Clinical Trial
Official title:
A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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