PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH METASTATIC BREAST CANCER

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically documented breast adenocarcinoma Clinical or
radiologic evidence of metastatic disease required Histologic confirmation recommended if
evidence is equivocal Bidimensionally measurable disease required, i.e.: Lesion with
clearly defined margins on physical exam or radiologic evaluation with 1 diameter greater
than 0.5 cm Lytic bone metastases only if measurable on bone x-ray/survey Lesion
previously irradiated only if subsequent measurable progression New measurable lesion in
previously irradiated field The following are not considered measurable: Unidimensionally
measurable lesions Palpable nodal disease not measurable on CT Masses with margins not
clearly defined Lesions with both diameters less than 0.5 cm Bone disease other than lytic
bone disease Pleural effusions or ascites Disease identified by bone scan only History of
bilateral breast cancer allowed No brain metastases CT required if clinically indicated No
meningeal carcinomatosis Hormone receptor status: Any status

PATIENT CHARACTERISTICS: Age: Over 18 Sex: Women only Menopausal status: Not specified
Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute
granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 1.5 mg/dL Other: No second
malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer
Adequately treated carcinoma in situ of the cervix Not pregnant or nursing Negative
pregnancy test required of premenopausal women Appropriate contraception required of
fertile women Blood/body fluid analyses to determine eligibility and physical exams for
tumor measurement completed within 7 days prior to registration; imaging studies to
evaluate and document measurable disease completed within 4 weeks prior to registration

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
prior chemotherapy for metastatic disease allowed At least 4 weeks since adjuvant
chemotherapy Endocrine therapy: Prior hormonal therapy allowed At least 4 weeks since
hormonal therapy for patients with partial or complete response to most recent maneuver
Radiotherapy: Prior radiotherapy for metastatic disease allowed At least 4 weeks since
radiotherapy and recovered Surgery: Not specified