Phase II trial of piroxantrone in advanced squamous cell carcinoma of the cervix: a Gynecological Oncology Group study.

Piroxantrone was administered at a starting dose of 160 mg m2 given as a 1-h infusion every 3 weeks to 19 patients with histologically confirmed advanced, persistent, or recurrent squamous cell carcinoma of the cervix. All patients were required to have measurable disease and no prior chemotherapy. Eighteen women were evaluable for toxicity and response. Toxicity was modest and consisted primarily of myelosuppression with six (33%) patients experiencing grade 3 or 4 leukopenia. There were no complete (CR) or partial responses (PR) among the 18 evaluable patients. Six (33%) patients had stable disease while on treatment and 12 (67%) patients experienced progressive disease. Piroxantrone appears to have no beneficial effect in advanced or recurrent squamous cell cancer of the cervix at this dose and schedule.