Phase II trial of piperazinedione (NCS 135758) in the treatment of advanced or recurrent squamous cell carcinoma of the cervix

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Abstract
THIRTY-EIGHT PATIENTS WITH ADVANCED or recurrent squamous cell carcinoma of the cervix no longer amenable to management with surgery and/or radiotherapy were given piperazinedione 9 mg/m2 intravenously every 3 weeks. Five (13%) experienced either complete or partial regression of disease, while 13 (34%) demonstrated stable disease. Responses were relatively short (median 3 months) with responders surviving significantly longer than nonresponders (median 20.3 months vs. 3.0 months, p = 0.01). Adverse effects consisted primarily of myelosuppression (61%) and nausea and vomiting (47%) and generally were mild to moderate and tolerable. The drug has minimal activity and tolerable adverse effects and could be considered for trials of combination chemotherapy in this disease.