Spots Global Cancer Trial Database for Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy

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Trial Identification

Brief Title: Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy

Official Title: A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer

Study ID: NCT00070031

Conditions

Breast Cancer

Interventions

edotecarin

Study Description

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.