PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH METASTATIC BREAST CANCER
OBJECTIVES: I. Assess the efficacy of pyrazoloacridine (PZA) administered by 3-hour infusion
in women with metastatic breast cancer. II. Assess the qualitative and quantitative
toxicities of PZA on this schedule. III. Assess the response duration and survival of
patients treated with this agent.
OUTLINE: All patients receive intravenous pyrazoloacridine (PZA) every 3 weeks in the
absence of progressive disease or unacceptable toxicity. Therapy continues in responding
patients until 6 months after a complete response or for 1 year, whichever is shorter;
stable patients receive a maximum of 4 courses. The dose is increased once for patients who
experience minimal toxicity. Patients who fail PZA are encouraged to continue therapy with
cyclophosphamide/doxorubicin/fluorouracil (CAF). All patients are followed for survival.
Prophylactic granulocyte colony-stimulating factor is not permitted.
PROJECTED ACCRUAL: Up to 20 patients will be accrued over 7-12 months. If no more than 1
response is seen in the first 12 evaluable patients, accrual will cease.
Primary Purpose: Treatment
Patricia M. LoRusso, DO
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|