Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer

Inclusion Criteria

• •Patients must have histologically or cytologically confirmed invasive breast cancer; patients without pathologic or cytologic evidence of metastatic disease should have unequivocal evidence of metastasis on radiographic study or physical exam; patients must have metastatic (stage IV) breast cancer, or locally advanced (stage IIIB) breast cancer that cannot be treated with curative intent
• •Patients must have measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm with conventional techniques; lytic bone lesions meeting these criteria will be considered measurable disease
• •Patients are required to have had at least one prior chemotherapy regimen for advanced breast cancer unless they have progressed within 12 months of concluding adjuvant chemotherapy; patients may not have had more than 2 prior chemotherapy regimens for advanced breast cancer; treatment with high-dose chemotherapy and stem cell support in the metastatic setting, including induction chemotherapy, will be considered 2 treatment regimens; patients may have received adjuvant chemotherapy; patients who have metastatic breast cancer diagnosed within 12 months of concluding adjuvant chemotherapy will be eligible after 0 or 1 regimens in the metastatic setting; patients may have received prior hormonal therapy of any type; patients may have been previously treated with investigational agents or biological agents (e.g. Herceptin)
• •Patients must have concluded prior therapy no less than the duration of one cycle of treatment prior to beginning treatment with rebeccamycin analog, but in all cases there must be at least a 2 week interval since last treatment; thus, if a patient is receiving therapy every three weeks, the patient must be at least three weeks from the last treatment before beginning protocol-based therapy; patients must have recovered from the toxicities of prior therapy, and meet the performance status and laboratory criteria for eligibility before beginning treatment
• •Patients may not receive concurrent anti-neoplastic therapy; all other radiation therapy, hormonal therapy, or treatment with trastuzumab (Herceptin) must be stopped prior to treatment on protocol; patients receiving bisphosphonate therapy may continue to receive these treatments while on protocol
• •Life expectancy of greater than 3 months
• •ECOG performance status =\< 1 (Karnofsky \>= 70%)
• •Absolute neutrophil count (ANC) \>= 1,500/uL
• •Platelets \>= 100,000/uL
• •Total bilirubin within normal institutional limits
• •AST(SGOT)/ALT(SGPT) =\< 2.5 x institutional upper limit of normal
• •Creatinine =\< 2 mg/dl
• •Sodium (Na) within normal institutional limits
• •Serum lipase within normal institutional limits
• •Serum amylase within normal institutional limits
• •Because rebeccamycin analog has been associated with phlebitis, all therapy on protocol will be given through a central venous line; patients not willing to have a central line, or those in whom central venous access could not be established, will not be eligible
• •The effects of rebeccamycin analog on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation; women should not become pregnant or nurse, nor expect to become pregnant or nurse, during the study; women in whom there is a suspicion of possible pregnancy must have a documented negative serum pregnancy test prior to beginning therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• •Ability to understand and the willingness to sign a written informed consent document