@article{8dec4d37c3564aa6bea7e2f5217c4c5a,
title = "Randomized Phase II Trial of Irinotecan/Docetaxel or Irinotecan/Docetaxel Plus Cetuximab for Metastatic Pancreatic Cancer: An Eastern Cooperative Oncology Group Study",
abstract = "Objectives: 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 and Methods: Patients were eligible who had measurable, metastatic adenocarcinoma of the pancreas, and normal bilirubin. All patients received anticoagulation. Docetaxel (35 mg/m2) and irinotecan (50 mg/m2) 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. Results: 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. Conclusions: 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.",
keywords = "cetuximab, docetaxel, irinotecan, pancreatic cancer",
author = "Barbara Burtness and Mark Powell and Paul Catalano and Jordan Berlin and Liles, {Darla K.} and Chapman, {Andrew E.} and Edith Mitchell and Benson, {Al B.}",
note = "Funding Information: From the *Department of Medical Oncology, Fox Chase Cancer Center; 8Department of Internal Medicine, Thomas Jefferson University School of Medicine, Philadelphia, PA; wDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA; zVanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN; yEast Carolina University School of Medicine, Greenville, NC; and zLurie Cancer Center, Northwestern University, Chicago, IL. Supported by Grant CA-23318, awarded by the National Cancer Institute, DHHS; Bristol-Myers Squibb; Sanofi; and Pharmacia. Dr Burtness reports having served as a consultant for Bristol-Myers Squibb, Sanofi-Aventis, Imclone, Lilly and Pharmacia. Dr Berlin reports having served as a consultant for Imclone and Lilly. Dr. Mitchell reports having served as a consultant for Sanofi-Aventis. Dr Benson reports having served as a consultant for Imclone, Lilly, Bristol-Myers Squibb, and Sanofi-Aventis. The remaining authors declare no conflicts of interest. Reprints: Barbara Burtness, MD, Section of Medical Oncology, Depart-ment of Internal Medicine, Yale University School of Medicine, 333 Cedar Street, PO Box 208028, WWW225, New Haven, CT 06520-2028. E-mail: barbara.burtness@yale.edu. Copyright {\textcopyright} 2014 Wolters Kluwer Health, Inc. All rights reserved. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. ISSN: 0277-3732/16/3904-0340 DOI: 10.1097/COC.0000000000000068 Publisher Copyright: Copyright {\textcopyright} 2014 Wolters Kluwer Health, Inc. All rights reserved.",
year = "2016",
month = aug,
day = "1",
doi = "10.1097/COC.0000000000000068",
language = "English (US)",
volume = "39",
pages = "340--345",
journal = "American Journal of Clinical Oncology: Cancer Clinical Trials",
issn = "0277-3732",
publisher = "Lippincott Williams and Wilkins",
number = "4",
}
