OBJECTIVES:

• Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven.
• Assess the qualitative and quantitative toxic effects of this drug in these patients.
• 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.

PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 12 months.

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

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• Not specified

Sex:

• Male or female

Menopausal status:

• Not specified

Performance status:

• SWOG 0-2

Life expectancy:

• Not specified

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:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• No prior irofulven

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified