Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer
Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
 they stop growing or die.

 PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating women who
 have refractory metastatic breast cancer.
OBJECTIVES: I. Determine the efficacy of pyrazoloacridine in patients with refractory breast
 cancer. II. Determine the toxic effects of pyrazoloacridine in these patients.

 OUTLINE: Patients receive pyrazoloacridine IV over 3 hours. Treatment repeats every 21 days
 for 2-8 courses in the absence of disease progression or unacceptable toxicity.

 PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 1 year.
DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Bidimensionally
 measurable disease of any of the following types required: Bidimensionally measurable lung
 lesions on chest X-ray, CT scan, or MRI Palpable and quantifiable lymph nodes at least 2 x
 2 cm Abdominal mass at least 2 x 2 cm quantifiable by CT scan Bidimensionally measurable
 liver metastases at least 2 x 2 cm Palpable hepatomegaly if liver edge is clearly defined
 and extends at least 5 cm below the costal margin of the xiphoid process Unacceptable as
 measurable disease: Diffuse lung infiltration or unidimensionally measurable hilar lesions
 Pelvic mass of indefinite dimension Bone metastases Pleural effusion or ascites No brain
 metastases Must have failed or progressed on prior therapy or relapsed less than 12 months
 after therapy discontinuation Hormone receptor status: Not specified

 PATIENT CHARACTERISTICS: Age: 16 and over Sex: Female Menopausal status: Not specified
 Performance status: SWOG 0-2 Life expectancy: At least 6 months Hematopoietic: Granulocyte
 count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than
 2.5 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no
 greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No
 history of congestive heart failure, myocardial infarction within past 6 months,
 ventricular arrhythmia, or ischemic heart disease requiring medication If necessary,
 ejection fraction at least 50% by MUGA Other: Not pregnant or nursing Negative pregnancy
 test Fertile patients must use effective contraception No other prior malignancies in past
 5 years other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ
 of the cervix No other serious illnesses or active infections No seizure disorder requiring
 anticonvulsant therapy

 PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
 See Disease Characteristics No more than 2 prior chemotherapy regimens for metastatic
 disease One prior adjuvant chemotherapy regimen for metastatic disease allowed At least 4
 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: One
 prior regimen of hormonal therapy for metastatic disease allowed At least 3 weeks since
 prior hormonal therapy and recovered No concurrent hormonal or corticosteroid therapy
 Radiotherapy: At least 4 weeks since prior radiotherapy to less than 25% bone marrow No
 concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No
 concurrent surgery Other: At least 4 weeks since any prior treatment directed at the tumor
 and recovered No other concurrent anticancer or investigational therapy No concurrent
 participation on another therapeutic clinical trial