A phase II study of gemcitabine and cisplatin in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix

Objective. The aim of this study was to determine the response rate and tox icity of cis-platinum and gemcitabine in advanced, recurrent, or persistent squamous cell carcinoma of the cervix. Methods. From July 1997 to January 1999, we conducted a Phase II trial in p atients with advanced, persistent, or recurrent carcinoma of the cervix. Th e schedule employed 1250 mg/m(2) of gemcitabine on days 1 and 8 and 50 mg/m (2) of cis-platinum on day 1 in a 21-day cycle. Eligibility criteria were a GOG performance status of 0-2, adequate bone marrow reserve, serum creatin ine less than 1.8 mg%, and a lesion which could be measured in two dimensio ns. None of the patients had received prior chemotherapy other than radiati on sensitizers. Standard GOG toxicity and response criteria were used. Results. Nineteen patients were enrolled into the trial. Two patients were inevaluable because of inadequate trial of drug. Seventeen patients were ev aluable for response and toxicity. The median age of the patients was 47 ye ars (range 24-72). The median number of cycles delivered was 5 (range 2-8). The incidence of grade 4 neutropenia and anemia was 2.4 and 1.2%, respecti vely. Two patients developed a single episode of grade 3 gastrointestinal t oxicity. The overall response rate was 41% (7/17). There was 1 complete res ponse of 14 months duration and 6 partial responses. Among those patients n ot previously irradiated, the response rate was 57% (4/7). Among the radiat ed patients, the response rate was 30% (3/10) with all responses occurring in the radiation field. Conclusion. This combination of cis-platinum and gemcitabine is a well-tole rated regimen which exhibits high activity in advanced, recurrent, or persi stent squamous cell cervical cancer. (C) 2000 Academic Press.