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Phase II Clinical Trial of Docetaxel in Refractory Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study

Garcia, Agustin A. MD*; Blessing, John A. PhD; Vaccarello, Luis MD; Roman, Lynda D. MD§

American Journal of Clinical Oncology: August 2007 - Volume 30 - Issue 4 - p 428-431
doi: 10.1097/COC.0b013e31803377c8
Original Article: Gynecologic
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Objective: A phase II study was conducted to evaluate the antitumor activity and adverse effects of docetaxel in patients with previously treated squamous cell carcinoma of the cervix.

Methods: Eligible patients were to have measurable disease and not more than one prior chemotherapy regimen. Docetaxel 100 mg/m2 was administered intravenously over 1 hour. This treatment was repeated every 21 days until progression of disease or adverse effects prohibited further therapy.

Results: Twenty-seven patients were entered onto this study, of whom 23 were eligible and evaluable. There were 2 (8.7%) partial responses. Eight patients (34.8%) had stable disease and 9 patients (39.1%) had increasing disease. The median time to progression was 3.8 months (range, 1.2–11.7 months), while median survival time was 7.0 months (range, 1.8–23.0 months). The most frequently reported adverse events were neutropenia, infection, gastrointestinal, and constitutional.

Conclusions: Docetaxel has minimal activity in refractory squamous cell carcinoma of the cervix at the dose and schedule tested.

From the *Premiere Oncology, Santa Monica, CA; †Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; ‡Gynecologic Oncology, Mount Carmel Health Center, Columbus, OH; and §Gynecologic Oncology, USC Keck School of Medicine, Los Angeles, CA.

Supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469) and the Gynecologic Oncology Group Statistical Office (CA 37517).

The following member institutions participated in this study: Duke University Medical Center, University of Minnesota Medical School, University of Mississippi Medical Center, University of Cincinnati, Indiana University School of Medicine, University of California Medical Center at Irvine, Tufts-New England Medical Center, Columbus Cancer Council, University of Massachusetts Medical School, University of Chicago, Tampa Bay Cancer Consortium, and Yale University.

Reprints: Denise Mackey, Gynecologic Oncology Group, Four Penn Center, 1600 JFK Blvd., Suite 1020, Philadelphia, PA 19103. E-mail: dmackey@gog.org.

© 2007 Lippincott Williams & Wilkins, Inc.