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Lead
National Cancer Institute (NCI)
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic adenocarcinoma of the breast
Measurable disease outside previously irradiated area or occurred/progressed after completion of radiotherapy
Must have received 1 or 2 prior chemotherapy regimens for metastatic disease
* More than 3 prior regimens allowed
No active brain metastases or meningeal breast cancer involvement
PATIENT CHARACTERISTICS:
Sex:
Male or female
Performance status:
SWOG 0-2
Hematopoietic:
WBC at least 3,000/mm\^3
Platelet count at least 100,000/mm\^3
Absolute neutrophil count at least 1,500/mm\^3
Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT or SGPT no greater than 3 times ULN (5 times ULN for liver metastases)
Renal:
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min
Cardiovascular:
No history of myocardial infarction or unstable angina within the past 6 months
No uncontrolled congestive heart failure
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Prior diagnosis of cancer allowed (must be off cancer therapy and have no evidence of disease)
No history of retinopathy and/or macular degeneration
PRIOR CONCURRENT THERAPY:
Chemotherapy:
No prior irofulven
Clareo Health | Irofulven in Treating Patients With Metastatic Breast Cancer
