Spots Global Cancer Trial Database for Irofulven in Treating Patients With Metastatic Breast Cancer
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Trial Identification
Brief Title: Irofulven in Treating Patients With Metastatic Breast Cancer
Official Title: Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer
Study ID: NCT00003796
Conditions
Interventions
Study Description
Brief Summary: Phase II trial to study the effectiveness of irofulven in treating patients who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description: OBJECTIVES: I. Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven. II. Assess the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic relationships of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Contact Details
Name: Lisa Hammond, MD
Affiliation: The University of Texas Health Science Center at San Antonio
Role: STUDY_CHAIR
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