A phase I study of cetuximab in combination with gemcitabine and radiation for locally advanced pancreatic cancer

A. Bapsi Chakravarthy, Chiao Jillian Tsai, Nathan O'Brien, A. Craig Lockhart, Emily Chan, Alexander Parikh, Jordan D. Berlin, Nipun Merchant

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

BACKGROUND: Cetuximab is a monoclonal antibody against the epidermal growth factor receptor (EGFR). The primary goal of this phase I study was to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of gemcitabine when combined with cetuximab plus radiation in patients with locally advanced pancreatic cancer. PATIENTS AND METHODS: Patients with locally unresectable adenocarcinoma of the pancreas were treated with gemcitabine (200mg/m2/week before dose escalation) plus cetuximab (400 mg/m 2 loading dose, 250 mg/m 2 weekly maintenance dose) concurrent with radiation (50.4 Gy). RESULTS: Nine patients were enrolled in the study. One withdrew due to declining performance status before receiving any therapy. Grade 4 allergic reactions to cetuximab caused the withdrawal of 2 patients. Another patient had elevated liver function test results and a stroke after his loading dose of cetuximab. Grade 3 or 4 toxicity developed in 3 of the remaining 5 patients treated with the level 1 dose. Therefore, no further dose escalations were planned. Grade 3 toxicities included nausea, vomiting, ileus, and pneumonitis. One patient had grade 4 diarrhea. CONCLUSIONS: The combination of cetuximab, gemcitabine, and radiation resulted in significant toxicity. A recommended phase II dose could not be determined.

Original languageEnglish (US)
Pages (from-to)112-118
Number of pages7
JournalGastrointestinal Cancer Research
Volume5
Issue number4
StatePublished - Jul 1 2012
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

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