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Paclitaxel, an Active Agent in Nonsquamous Carcinomas of the Uterine Cervix: A Gynecologic Oncology Group Study

From the Department of Obstetrics and Gynecology, Cornell University Medical College, Memorial Sloan-Kettering Cancer Center; Gynecologic Oncology, New York University School of Medicine, New York; Gynecologic Oncology Group, Cancer Research Scientist VI, Roswell Park Cancer Institute, Buffalo; Gynecologic Oncology, Albany Medical College, Albany, NY; Section of Gynecologic Oncology, Department of Gynecology, Cleveland Clinic Foundation; Case Western Reserve University, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University Hospitals of Cleveland, Cleveland, OH; Department of Obstetrics and Gynecology, Walter Reed Army Medical Center, Washington, DC; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of North Carolina School of Medicine, Chapel Hill, NC; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, AL.

Address reprint requests to GOG Administrative Office, Suite 1945, 1234 Market Street, Philadelphia, PA 19107.

PURPOSE: A phase II trial of paclitaxel was initiated in advanced nonsquamous carcinoma of the cervix to determine its activity in patients who had failed standard chemotherapy.

PATIENTS AND METHODS: Eligible patients had at least one measurable lesion. The starting dose of paclitaxel was 170 mg/m² (135 mg/m² for patients with prior pelvic radiation) given as a 24-hour continuous intravenous infusion with courses repeated every 3 weeks. Dose escalation to 200 mg/m² and de-escalation to 110 mg/m² were allowed based on adverse effects.

RESULTS: In this trial, 42 assessable patients were initially entered onto the study, and 13 responses were seen; four patients had a complete response, and nine patients had a partial response. The overall response rate was 31%. The primary and dose-limiting toxicity was neutropenia.

CONCLUSION: The response rate to paclitaxel exceeds the rates reported using other single agents in nonsquamous carcinoma of the cervix.

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