Irofulven in Treating Patients With Metastatic Breast Cancer
- Registration Number
- NCT00003796
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I irofulven 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.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States