title: A phase II study of biweekly pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinoma that have failed first-line platinum-based therapy.
abstract: BACKGROUND
  The appropriate second-line therapy for patients with advanced gastroesophageal (GE) or esophageal (E) cancer after failure of first-line platinum-based therapy is unclear. Pralatrexate and docetaxel have independently been shown to have efficacy in the treatment of these cancers. Thus, we performed a clinical trial examining the efficacy of the combination of these agents in the treatment of GE and E cancer.
  
  
  METHODS
  A Fleming phase II design with a single stage of 32 patients was planned. Pralatrexate 120 mg/m(2) and docetaxel 35 mg/m(2) were administered on day 1 of 14-day cycles. The primary end-point was to evaluate the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and secondary end-points were to evaluate for progression-free survival (PFS) and overall survival (OS).
  
  
  RESULTS
  The study was halted prematurely due to loss of funding after the accrual of six patients. Two patients had stable disease (SD) and four patients had disease progression per RECIST. When applying PERCIST criteria in four evaluable patients, two had a partial response (PR) and two had SD. Median PFS was 1.9 months (95% CI, 0.8-7.2) and median OS was 5.5 (0.8-11.7) months.
  
  
  CONCLUSIONS
  Pralatrexate and docetaxel as therapy in refractory esophageal and GE adenocarcinoma did not demonstrate meaningful preliminary activity. PERCIST may prove to better assess the meaningfulness of anatomic SD.
authors.affiliation: 1 Wexner Medical Center, 2 Center for Biostatistics, Comprehensive Cancer Center, 3 Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH 43210, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Petullo
authors.affiliation: 1 Wexner Medical Center, 2 Center for Biostatistics, Comprehensive Cancer Center, 3 Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH 43210, USA.
authors.forename: Lai
authors.initials: L
authors.lastname: Wei
authors.affiliation: 1 Wexner Medical Center, 2 Center for Biostatistics, Comprehensive Cancer Center, 3 Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH 43210, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Yereb
authors.affiliation: 1 Wexner Medical Center, 2 Center for Biostatistics, Comprehensive Cancer Center, 3 Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH 43210, USA.
authors.forename: Alison
authors.initials: A
authors.lastname: Neal
authors.affiliation: 1 Wexner Medical Center, 2 Center for Biostatistics, Comprehensive Cancer Center, 3 Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH 43210, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Rose
authors.affiliation: 1 Wexner Medical Center, 2 Center for Biostatistics, Comprehensive Cancer Center, 3 Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH 43210, USA.
authors.forename: Tanios
authors.initials: T
authors.lastname: Bekaii-Saab
authors.affiliation: 1 Wexner Medical Center, 2 Center for Biostatistics, Comprehensive Cancer Center, 3 Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH 43210, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Wu
keywords: Pralatrexate; docetaxel; esophageal (E) cancer; gastrointestinal neoplasms