title: Phase II study of gemcitabine, oxaliplatin, and cetuximab in advanced pancreatic cancer.
abstract: OBJECTIVE
  Little progress has been made in the treatment of pancreatic cancer (PC). This study evaluated the clinical activity of gemcitabine, oxaliplatin, and cetuximab (GOC) in patients with locally advanced or metastatic PC.
  
  
  METHODS
  The study primary endpoint was progression-free survival (PFS). Eligible, chemotherapy-naive PC patients were treated with gemcitabine (1000 mg/m(2) over 100 min) on day 1, oxaliplatin (100 mg/m(2)) on day 2, every 2 weeks, and weekly cetuximab, (loading dose of 400 mg/m(2) on cycle 1 day 1 and 250 mg/m(2) thereafter). It was expected that GOC treatment would extend the median PFS from 5.8 to 7.54 months, a relative increase of 30%, compared with gemcitabine and oxaliplatin (historical control).
  
  
  RESULTS
  A total of 41 evaluable patients were enrolled. The overall response rate was 24%. Median PFS time was 6.9 months and median overall survival (OS) was 11.3 months. Patients with locally advanced disease had longer median PFS (12.4 vs. 4.7 mo) and OS (15.7 vs. 6.4 mo) compared with patients with metastatic disease. The most common grade 3 to 4 toxicities included neutropenia (32%), infection (with normal or grade 1 to 2 neutropenia, in 24%), neuropathy (17%), fatigue (15%), and rash (7%). Five patients (12%) discontinued study treatment without evidence of progression. Rash was not a significant prognostic factor affecting PFS or OS.
  
  
  CONCLUSIONS
  GOC is a feasible combination with an acceptable toxicity profile. However, GOC did not significantly extend PFS in the overall patient population to consider it for further development.
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA. jmerchan2@med.miami.edu
authors.forename: Jaime R
authors.initials: JR
authors.lastname: Merchan
authors.forename: Annaporna
authors.initials: A
authors.lastname: Ferrell
authors.forename: Jessica
authors.initials: J
authors.lastname: Macintyre
authors.forename: Kristen K
authors.initials: KK
authors.lastname: Ciombor
authors.forename: Joe
authors.initials: J
authors.lastname: Levi
authors.forename: Afonso
authors.initials: A
authors.lastname: Ribeiro
authors.forename: Danny
authors.initials: D
authors.lastname: Sleeman
authors.forename: Aurea
authors.initials: A
authors.lastname: Flores
authors.forename: Gilberto
authors.initials: G
authors.lastname: Lopes
authors.forename: Caio M
authors.initials: CM
authors.lastname: Rocha-Lima
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000068818:Cetuximab; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000068818:Cetuximab; D000093542:Gemcitabine