Irofulven in Treating Patients With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Irofulven

Criteria

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