Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed primary adenocarcinoma of the breast
• * Locally advanced or metastatic disease
• Not amenable to surgery or radiotherapy with curative intent
• At least 1 unidimensionally measurable lesion
• * At least 20 mm by conventional techniques OR 10 mm by CT scan
• * Not previously irradiated
• Meets 1 of the following criteria:
• * Previously treated with anthracycline and concurrent or sequential taxane therapy
• * Refractory to the most recent taxane-based chemotherapy, defined as 1 of the following:
• * Progressive disease during therapy or within 4 months of the last dose with or without documented response for advanced disease
• * Progressive disease within 6 months of completing taxane-based chemotherapy as neoadjuvant therapy
• * Resistant to prior chemotherapy, as defined by progressive disease within 6 months of completing prior chemotherapy for advanced disease
• No known brain metastases or carcinomatous meningitis\* NOTE: \*Baseline CT scan or MRI of the brain required if there is clinical suspicion of CNS metastases
• No spinal cord compression
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Female
• Menopausal status
• Not specified
• Performance status
• ECOG 0-1
• Life expectancy
• Not specified
• Hematopoietic
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 9.0 g/dL
• Hepatic
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN (5 times ULN if liver involvement secondary to tumor is present)
• Albumin at least 3.0 g/dL
• Renal
• Creatinine no greater than 1.5 mg/dL
• Cardiovascular
• LVEF at least 50% or ULN by echocardiogram or MUGA
• None of the following within the past 6 months:
• * Myocardial infarction
• * Severe or unstable angina
• * Symptomatic congestive heart failure
• * Cerebrovascular accident or transient ischemic attack
• * Deep vein thrombosis or other significant thromboembolic event
• No ongoing cardiac dysrhythmias grade 2 or greater
• No atrial fibrillation of any grade
• Pulmonary
• No pulmonary embolism within the past 6 months
• Gastrointestinal
• No active inflammatory bowel disease
• No partial or complete bowel obstruction
• No chronic diarrhea
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No known HIV positivity
• No active infection
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or confound study results
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No concurrent biological response modifiers
• No concurrent immunotherapy
• No concurrent sargramostim (GM-CSF)
• No other concurrent granulocyte colony-stimulating factors
• Chemotherapy
• See Disease Characteristics
• Prior adjuvant chemotherapy allowed
• No prior topoisomerase I inhibitors
• No more than 2 prior chemotherapy regimens for advanced disease
• No prior high-dose chemotherapy that required hematopoietic stem cell rescue
• No other concurrent chemotherapy
• Endocrine therapy
• Prior adjuvant hormonal therapy or hormonal therapy for advanced/metastatic disease allowed provided that therapy is discontinued before study entry
• No concurrent hormonal therapy
• Radiotherapy
• See Disease Characteristics
• No prior radiotherapy to more than 25% of the bone marrow
• No concurrent radiotherapy during and for 5 days after study treatment
• * Palliative radiotherapy allowed provided no more than 20% of the bone marrow is involved
• Surgery
• No coronary/peripheral artery bypass graft within the past 6 months
• Other
• Recovered from prior therapy (except alopecia or neurotoxicity)
• At least 4 weeks since any other prior therapy
• More than 4 weeks since prior investigational agents
• No concurrent enrollment on another clinical trial
• No other concurrent approved or investigational anticancer treatment