Phase II trial of pyrazoloacridine in patients with persistent or recurrent endometrial carcinoma: a Gynecologic Oncology Group Study.

OBJECTIVES: The aims of this study were to determine the response rate of pyrazoloacridine (PZA) in patients with recurrent or persistent endometrial carcinoma and to describe the nature and degree of toxicity in this population.
METHODS: PZA was initially administered at a dose of 750 mg/m(2) intravenously over 3 h every 3 weeks but, due to toxicity, was subsequently reduced to 560 mg/m(2) at the same schedule.
RESULTS: Among 23 evaluable patients, 11 of whom had had prior chemotherapy, there was 1 (4.3%) partial response and no complete responses. Forty-eight percent of patients had grade 4 neutropenia. There was 1 treatment-related death, in a patient who had prior chemotherapy and radiotherapy.
CONCLUSION: This dose and schedule of PZA has insignificant activity in this population. The optimal PZA dose appears to vary between different populations and may be related to prior therapy. ©2001 Elsevier Science.