Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer

Metastatic (stage IV) disease

Relapsed after 1 of the following prior therapy regimens*:

Adjuvant therapy containing an anthracycline and a taxane
Adjuvant anthracycline therapy followed by first-line metastatic treatment containing a taxane NOTE: *No relapse within 12 months of initiation of prior therapy

Measurable disease by CT scan or MRI

No ascites, pleural effusions, or osteoblastic bone metastases as the only site of measurable disease
Refractory to hormonal anticancer therapy completed more than 4 weeks before study therapy

HER2/neu positive allowed provided patient received prior trastuzumab (Herceptin®)

MUGA or echocardiogram normal while on trastuzumab
No known history of or current brain or leptomeningeal metastases

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age

Over 18

Sex

Female

Menopausal status

Not specified

Performance status

ECOG 0-2

Life expectancy

At least 12 weeks

Hematopoietic

WBC at least 3,000/mm^3
Neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10.0 g/dL
No clinically significant abnormal hematological parameters

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in case of liver metastases)
AST or ALT no greater than 2.5 times ULN (5 times ULN in case of liver metastases)

Renal

Creatinine no greater than 1.5 times ULN

Cardiovascular

See Disease Characteristics
No myocardial infarction within the past 3 months
No unstable angina pectoris
No New York Heart Association class III or IV heart disease
No uncontrolled arrhythmia
No cardiac insufficiency
No uncontrolled hypertension
LVEF at least 50% OR at least lower limit of normal

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception 4 weeks before, during, and for at least 4 weeks after study participation
No preexisting neuropathy (motor or sensory) greater than grade 2
No clinically significant abnormal biochemical parameters
No clinically significant active infection
No other prior malignancy except cured nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
No other serious illness or medical condition
No psychological illness or condition that would preclude study participation
No other known condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
More than 3 months since prior trastuzumab
More than 2 weeks since prior growth factor therapy (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF])
No concurrent systemic anticancer immune modulators

Chemotherapy

See Disease Characteristics

Endocrine therapy

See Disease Characteristics
More than 4 weeks since prior hormonal therapy
No concurrent anticancer hormonal therapy

No concurrent chronic systemic steroids

Concurrent topical or inhaled steroids for dermatological or allergy/asthma conditions allowed provided therapy was initiated prior to study enrollment
Concurrent hormone replacement therapy allowed provided therapy was initiated prior to study enrollment

Radiotherapy

More than 30 days since prior radiotherapy
No concurrent radiotherapy directed at target lesions

Surgery

At least 4 weeks since prior major surgery and recovered

Other

More than 30 days since prior investigational new drug
More than 2 weeks since prior blood transfusion
No other concurrent systemic anticancer agents, including immunosuppressive agents
No other concurrent investigational agents
Concurrent bisphosphonates allowed provided therapy was initiated prior to study enrollment