Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer

Date de début de l'étude : 1 mai 1999

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