Phase II trials of cisplatin and piperazinedione in advanced or recurrent squamous cell carcinoma of the vulva: a Gynecologic Oncology Group Study.

Thirty-eight patients with advanced or recurrent squamous cell carcinoma of the vulva no longer amenable to control with surgery and/or radiotherapy were entered onto one of two phase II studies. One was deemed ineligible because of a primary site of origin other than vulva. Of the remaining 37, 13 patients received piperazinedione 9 mg/m2 iv every 3 weeks. No objective regressions were observed. Five patients were judged to have had stable disease, while eight demonstrated increasing disease. The other 24 patients received cisplatin 50 mg/m2 iv every 3 weeks. Of the 22 who were evaluable for response because of the presence of measurable disease, no objective regression of disease was observed. Ten had stable disease, while the remaining 12 had increasing disease. Adverse effects were tolerable for each study agent and were essentially those reported in other series for these two drugs. These results suggest that neither agent is active in advanced or recurrent squamous cell carcinoma of the vulva at least at the dose and schedule tested.