Article Text

Download PDFPDF
Phase II evaluation of capecitabine in refractory nonsquamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study
  1. K. Y. Look*,
  2. J. A. Blessing,
  3. C. M. Michener,
  4. S. C. Rubin§ and
  5. P. T. Ramirez
  1. *Department of Obstetrics-Gynecology, Indiana University School of Medicine, Indianapolis, Indiana;
  2. Gynecologic Oncology Group Statistical
  3. & Data Center, Roswell Park Cancer Center, Buffalo, New York;
  4. Department of Obstetrics and Gynecology, The Cleveland Clinic Foundation, Cleveland, Ohio;
  5. § Gynecologic Oncology, University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania; and
  6. Department of GYN Oncology, MD Anderson Cancer Center, Houston, Texas
  1. Address correspondence and reprint requests to: Katherine Y. Look, MD, Department of Obstetrics-Gynecology, Indiana University School of Medicine, 550 N. University Boulevard, Room 434 Indianapolis, IN 46202. Email: klook7711{at}sbcglobal.net; and Ms Denise Mackey, GOG Administrative Office, Four Penn Center, 1600 JFK Boulevard, Suite 1020, Philadelphia, PA 19103. Email: dmackey{at}gog.org

Abstract

We conducted a multi-institutional study to assess the activity and toxicity of capecitabine in patients with persistent or recurrent nonsquamous cancer of the cervix. Eligible patients were required to possess adequate renal, hepatic and bone marrow function and a Gynecologic Oncology Group performance status of 0–2. Histologic confirmation of the original primary cancer was mandated. Patients must have received one prior systemic chemotherapeutic regimen for cervical cancer that did not include the chemotherapy that may have been administered in conjunction with prior radiation therapy. The initial dose schedule was 2500 mg/m2 orally daily in two divided doses for 14 consecutive days, followed by a 7-day rest, such that each cycle was 21 days. Responses were assessed using response evaluation criteria in solid tumors. Twenty-one patients were entered into the trial. One patient was declared ineligible for wrong cell type; thus, 20 were evaluable for toxicity. A median of 2.5 cycles was administered (range 1–11). There was one septic death. Grade 4 neutropenia, renal, neurologic, and pulmonary toxicity was seen in 5%, 5%, 5%, and 10% patients, respectively. There were no responses. Nine patients (45%) each had stable disease and nine showed progression. The remaining two cases (10%) did not have subsequent disease assessment and response could not be assessed. Oral capecitabine at the dose and schedule tested has insignificant activity in nonsquamous cervical cancer patients previously treated with chemotherapy.

  • capecitabine
  • nonsquamous cervical carcinoma

Statistics from Altmetric.com

Footnotes

  • K.Y. Look is presently employed by Eli Lilly.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.