title: Pemetrexed and cisplatin for the treatment of advanced, persistent, or recurrent carcinoma of the cervix: a limited access phase II trial of the gynecologic oncology group.
abstract: OBJECTIVE
  To estimate the antitumor activity of pemetrexed and cisplatin with objective tumor response (partial and complete) in patients with advanced, persistent, or recurrent carcinoma of the cervix and to determine the nature and degree of toxicity of this regimen. Secondarily, this study will determine the effects of this regimen on progression-free survival and overall survival.
  
  
  METHODS
  Eligible, consenting patients received pemetrexed 500 mg/m(2) and cisplatin 50 mg/m(2) intravenously repeated every 21 days until disease progression or adverse events prohibited further therapy. Patients received no prior therapeutic chemotherapy, except when administered concurrently with primary radiation therapy. Subsequent doses were adjusted according to observed toxicity and protocol guidelines. Adverse events were assessed with Common Terminology Criteria for Adverse Events v 3.0. The primary measure of efficacy was tumor response according to Response Evaluation Criteria in Solid Tumors. The study was stratified by prior radiation therapy.
  
  
  RESULTS
  From September 2008 to November 2011, 55 patients were enrolled by five Gynecologic Oncology Group member institutions; of those, 54 patients were eligible and assessable. The regimen was well tolerated with 26% receiving more than nine cycles. The most common greater than grade 2 toxicities were neutropenia 35%, leukopenia 28%, and metabolic 28%. The overall response rate was 31% (one complete and 16 partial). The median progression-free survival was 5.7 months, and overall survival was 12.3 months.
  
  
  CONCLUSIONS
  Pemetrexed in combination with cisplatin demonstrates activity in the treatment of advanced, persistent, or recurrent carcinoma of the cervix.
authors: David Scott Miller, University of Texas Southwestern Medical Center, Dallas; Lois M. Ramondetta and Jubilee Brown, MD Anderson Cancer Center, Houston, TX; John A. Blessing, Roswell Park Cancer Institute, Buffalo, NY; Huyen Q. Pham, University of Southern California, Los Angeles; Krishnansu S. Tewari, University of California Medical Center at Irvine, Orange, CA; and Lisa M. Landrum and Robert S. Mannel, University of Oklahoma, Oklahoma City, OK. david.miller@utsouthwestern.edu.
authors: David Scott
authors: DS
authors: Miller
authors: David Scott Miller, University of Texas Southwestern Medical Center, Dallas; Lois M. Ramondetta and Jubilee Brown, MD Anderson Cancer Center, Houston, TX; John A. Blessing, Roswell Park Cancer Institute, Buffalo, NY; Huyen Q. Pham, University of Southern California, Los Angeles; Krishnansu S. Tewari, University of California Medical Center at Irvine, Orange, CA; and Lisa M. Landrum and Robert S. Mannel, University of Oklahoma, Oklahoma City, OK.
authors: John A
authors: JA
authors: Blessing
authors: David Scott Miller, University of Texas Southwestern Medical Center, Dallas; Lois M. Ramondetta and Jubilee Brown, MD Anderson Cancer Center, Houston, TX; John A. Blessing, Roswell Park Cancer Institute, Buffalo, NY; Huyen Q. Pham, University of Southern California, Los Angeles; Krishnansu S. Tewari, University of California Medical Center at Irvine, Orange, CA; and Lisa M. Landrum and Robert S. Mannel, University of Oklahoma, Oklahoma City, OK.
authors: Lois M
authors: LM
authors: Ramondetta
authors: David Scott Miller, University of Texas Southwestern Medical Center, Dallas; Lois M. Ramondetta and Jubilee Brown, MD Anderson Cancer Center, Houston, TX; John A. Blessing, Roswell Park Cancer Institute, Buffalo, NY; Huyen Q. Pham, University of Southern California, Los Angeles; Krishnansu S. Tewari, University of California Medical Center at Irvine, Orange, CA; and Lisa M. Landrum and Robert S. Mannel, University of Oklahoma, Oklahoma City, OK.
authors: Huyen Q
authors: HQ
authors: Pham
authors: David Scott Miller, University of Texas Southwestern Medical Center, Dallas; Lois M. Ramondetta and Jubilee Brown, MD Anderson Cancer Center, Houston, TX; John A. Blessing, Roswell Park Cancer Institute, Buffalo, NY; Huyen Q. Pham, University of Southern California, Los Angeles; Krishnansu S. Tewari, University of California Medical Center at Irvine, Orange, CA; and Lisa M. Landrum and Robert S. Mannel, University of Oklahoma, Oklahoma City, OK.
authors: Krishnansu S
authors: KS
authors: Tewari
authors: David Scott Miller, University of Texas Southwestern Medical Center, Dallas; Lois M. Ramondetta and Jubilee Brown, MD Anderson Cancer Center, Houston, TX; John A. Blessing, Roswell Park Cancer Institute, Buffalo, NY; Huyen Q. Pham, University of Southern California, Los Angeles; Krishnansu S. Tewari, University of California Medical Center at Irvine, Orange, CA; and Lisa M. Landrum and Robert S. Mannel, University of Oklahoma, Oklahoma City, OK.
authors: Lisa M
authors: LM
authors: Landrum
authors: David Scott Miller, University of Texas Southwestern Medical Center, Dallas; Lois M. Ramondetta and Jubilee Brown, MD Anderson Cancer Center, Houston, TX; John A. Blessing, Roswell Park Cancer Institute, Buffalo, NY; Huyen Q. Pham, University of Southern California, Los Angeles; Krishnansu S. Tewari, University of California Medical Center at Irvine, Orange, CA; and Lisa M. Landrum and Robert S. Mannel, University of Oklahoma, Oklahoma City, OK.
authors: Jubilee
authors: J
authors: Brown
authors: David Scott Miller, University of Texas Southwestern Medical Center, Dallas; Lois M. Ramondetta and Jubilee Brown, MD Anderson Cancer Center, Houston, TX; John A. Blessing, Roswell Park Cancer Institute, Buffalo, NY; Huyen Q. Pham, University of Southern California, Los Angeles; Krishnansu S. Tewari, University of California Medical Center at Irvine, Orange, CA; and Lisa M. Landrum and Robert S. Mannel, University of Oklahoma, Oklahoma City, OK.
authors: Robert S
authors: RS
authors: Mannel
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D000068437:Pemetrexed; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D002945:Cisplatin