Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 4174
© 2005 American Society of Clinical Oncology

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Abstract

A phase II trial of gemcitabine and celecoxib for metastatic pancreatic cancer

MD Anderson Cancer Ctr, Houston, TX; MD Anderson Cancer Ctr Orlando, Orlando, FL; Cancer Research for the Ozarks, Springfield, MO; Marshfield Clinic, Marshfield, WI

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Background: Overexpression of cyclooxygenase-2 (COX2) is detected in 75% of resected pancreatic cancer and correlates with aggressive tumor biology. COX 2 promotes tumor growth by upregulating angiogenesis and invasiveness, and inhibiting apoptosis. Celecoxib, a COX 2 specific inhibitor, has demonstrated anti-tumor activity against a variety of human cancers in animal models, including pancreatic cancer xenografts. The primary objective of this study is to determine the overall survival at 6 months for patients with metastatic pancreatic cancer. Methods: The study is being conducted through the community clinical oncology research base affiliated with M. D. Anderson Cancer Center, and the target accrual is 40 patients. Eligible patients have biopsy proven metastatic pancreatic cancer (locally advanced disease was excluded), ECOG performance status 0–2, radiographic evidence of disease, adequate organ and marrow functions, and no prior treatment for metastatic disease. Gemcitabine is administered at 650 mg/m² over a 65-minute infusion days 1, 8, and 15 every 4 weeks and celecoxib 400 mg administered orally twice a day continuously. Results: Twenty-eight (13 female and 15 male) patients have enrolled into the study so far. Median age is 67 years old, ranging from 40 to 83. The Kaplan-Meier median survival duration is 6.2 months for 20 patients with complete follow-up data. The 3-months survival rate is 72%. Grade 3 or 4 thrombocytopenia and neutropenia developed in two patients each. Clinically relevant treatment related grade 3 or 4 non-hematological toxicities include nausea/vomiting (3 patients), supraventricular arrhythmia (1), dyspnea (1), pleural effusion (1), gastrointestinal bleeding (1), and hyponatremia (1). Conclusions: The combination of gemcitabine and celecoxib is active and can be delivered with acceptable toxicity to patients with metastatic pancreatic cancer.

No significant financial relationships to disclose.