Literature DB >> 20216081

Phase II trial of gemcitabine, irinotecan, and celecoxib in patients with advanced pancreatic cancer.

Allan Lipton1, Cynthia Campbell-Baird, Lois Witters, Harold Harvey, Suhail Ali.   

Abstract

GOALS AND
BACKGROUND: Cyclooxygenase-2 (COX-2) has been shown to be expressed in a variety of tumors including pancreatic cancer. The combination of gemcitabine and irinotecan is active in pancreatic cancer. The purpose of this study is to determine the toxicity and response rate to the addition of the selective oral COX-2 inhibitor, celecoxib, to gemcitabine and irinotecan in patients with inoperable pancreatic cancer. STUDY: Twenty-one patients with previously untreated inoperable pancreatic cancer were entered on this trial. Seven patients had localized disease, 8 had metastatic disease, and 6 patients were inevaluable.
RESULTS: Twenty percent of the patients had a partial response and 80% of the patients had a stable response with a median response rate of 9 months. The median overall survival was 18 months with 80% of the patients achieving 1-year survival and 20% achieving 2-year survival. Using the FACT-PA scale to measure the quality of life (QOL), 13 of the 15 patients reported an improvement in their QOL and 2 patients reported no change. The median CA19-9 levels for the 13 patients with measurable CA19-9 values, decreased by 71% by cycle 2. Adverse events were acceptable and included neutropenia, thrombocytopenia, nausea, fatigue, and anemia.
CONCLUSIONS: The combination of gemcitabine, irinotecan, and celecoxib is an active therapy for inoperable pancreatic cancer. A marked reduction in CA19-9 is observed in all evaluable patients by cycle 2. Toxicity is tolerable and a majority of patients reported a decrease in pain and a significant improvement in their QOL.

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Year:  2010        PMID: 20216081     DOI: 10.1097/MCG.0b013e3181cda097

Source DB:  PubMed          Journal:  J Clin Gastroenterol        ISSN: 0192-0790            Impact factor:   3.062


  26 in total

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