title: Randomized Phase II Trial of Irinotecan/Docetaxel or Irinotecan/Docetaxel Plus Cetuximab for Metastatic Pancreatic Cancer: An Eastern Cooperative Oncology Group Study.
abstract: The primary objective was to determine the response rate in patients with metastatic pancreatic cancer treated in first line with irinotecan/docetaxel combination (Arm A) or with irinotecan/docetaxel/cetuximab combination (Arm B). Secondary endpoints were progression-free survival (PFS), overall survival (OS), toxicity, and the rate of thromboembolic events with prophylactic enoxaparin sodium.
  
  
  
  Patients were eligible who had measurable, metastatic adenocarcinoma of the pancreas, and normal bilirubin. All patients received anticoagulation. Docetaxel (35 mg/m) and irinotecan (50 mg/m) were administered once a week for 4 weeks followed by 2 weeks rest (Arm A) alone or with the addition of cetuximab (Arm B). The primary endpoint was response rate.
  
  
  
  A total of 87 eligible patients were enrolled and treated. Grade 3/4 toxicity was observed in 74% of patients in Arm A and 76% in Arm B. The principal grade 3/4 toxicity was diarrhea. Response rates were 4.5% in Arm A and 7% in Arm B. Median PFS and OS were 3.9 and 6.5 months in Arm A and 4.5 and 5.4 months in Arm B.
  
  
  
  Docetaxel/irinotecan combination is associated with considerable toxicity. Objective responses were infrequent and addition of cetuximab in an unselected population was not beneficial, but PFS and OS were comparable with those achieved with other regimens. Docetaxel/irinotecan therapy is active in metastatic pancreatic cancer.
authors.affiliation: *Department of Medical Oncology, Fox Chase Cancer Center ∥Department of Internal Medicine, Thomas Jefferson University School of Medicine, Philadelphia, PA †Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA ‡Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN §East Carolina University School of Medicine, Greenville, NC ¶Lurie Cancer Center, Northwestern University, Chicago, IL.
authors.forename: Barbara
authors.initials: B
authors.lastname: Burtness
authors.forename: Mark
authors.initials: M
authors.lastname: Powell
authors.forename: Paul
authors.initials: P
authors.lastname: Catalano
authors.forename: Jordan
authors.initials: J
authors.lastname: Berlin
authors.forename: Darla K
authors.initials: DK
authors.lastname: Liles
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Chapman
authors.forename: Edith
authors.initials: E
authors.lastname: Mitchell
authors.forename: Al B
authors.initials: AB
authors.lastname: Benson
mesh_terms: D000230:Adenocarcinoma / Q000150:complications / Q000188:drug therapy* / Q000556:secondary; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018395:CA-19-9 Antigen / Q000097:blood; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000068818:Cetuximab / Q000008:administration & dosage; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D000077143:Docetaxel; D017984:Enoxaparin / Q000627:therapeutic use; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D066066:Response Evaluation Criteria in Solid Tumors; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D013923:Thromboembolism / Q000209:etiology / Q000517:prevention & control
chemical_list: D000925:Anticoagulants; D018395:CA-19-9 Antigen; D017984:Enoxaparin; D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D000068818:Cetuximab; D002166:Camptothecin