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A Phase II Trial of Erlotinib in Recurrent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study
  1. Russell J. Schilder, MD*,
  2. Michael W. Sill, PhD,
  3. Yi-Chun Lee, MD and
  4. Robert Mannel, MD§
  1. *Fox Chase Cancer Center, Philadelphia, PA;
  2. GOG Statistical and Data Center, Buffalo, NY;
  3. SUNY Health Science Center at Brooklyn, Brooklyn, NY;
  4. §University of Oklahoma, Oklahoma City, OK.
  1. Address correspondence and reprint requests to Russell J. Schilder, MD, Department of Medical Oncology, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA 19111. E-mail: russell.schilder{at}


Objectives: To determine the proportion of patients with tumor response, the proportion who survived progression-free for at least 6 months (progression-free survival ≥ 6 months), and the frequency and severity of toxicities of patients with recurrent squamous cell carcinoma of the uterine cervix treated with erlotinib.

Methods: This was a multicenter, open-label, single-arm trial evaluating the toxicity and efficacy of oral erlotinib at an initial dosage of 150 mg daily until progressive disease or adverse effects prohibited further therapy.

Results: Twenty-eight patients with squamous cell carcinoma were enrolled onto this trial. Twenty-five patients were evaluable. There were no objective responses, with 4 (16%) patients achieving stable disease; only 1 patient had a progression-free survival of 6 months (4%) or more. The 1-sided 90% confidence interval for response was 0.0% to 8.8%. The 2-sided 90% confidence interval for the proportion of patients surviving progression-free for at least 6 months is 0.2% to 17.6%. Erlotinib was well tolerated, with the most common drug-related adverse events being gastrointestinal toxicities, fatigue, and rash.

Conclusions: Erlotinib is inactive as monotherapy in patients with recurrent squamous cell carcinoma of the uterine cervix.

  • Cervical cancer
  • EGFR
  • Erlotinib

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  • This study was supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469) and Statistical Office (CA 37517). The following member institutions participated in this study: Roswell Park Cancer Institute, Abington Memorial Hospital, University of Pennsylvania Cancer Center, Milton S. Hershey Medical Center, University of Texas Southwestern Medical Center at Dallas, Wake Forest University School of Medicine, SUNY Downstate Medical Center, The Cleveland Clinic Foundation, Fox Chase Cancer Center, University of Oklahoma, Tacoma General Hospital, Case Western Reserve University, and Community Clinical Oncology Program.