P2-103 - A Phase II Trial of Gemcitabine in Combination with Oxaliplatin and Capecitabine in Previously Untreated Metasetatic or Recurrent Pancreatic Cancer

Abstract

ABSTRACT Background Treatment with single-agent gemcitabine provides modest benefits in patients with metastatic pancreatic cancer. This study was carried out to determine the efficacy of gemcitabine in combination with oxaliplatin and capecitabine in patient with recurrent or metastatic pancreatic adenocarcinoma. Methods This was a prospective, single-arm, single-center study in patients with chemotherapy-naive metastatic or recurrent pancreatic adenocarcinoma. The primary end point was objective response. The study was designed as a Simons two-stage optimal design and was divided into two stages. The first stage was to recruit up to 18 patients. If at least two objective responses were obtained, then a further 25 patients would be enrolled into the study. If no more than two responses were obtained among these 18 patients, the study would be halted. The study patients received gemcitabine 800 mg/m2 on day 1, plus oxaliplatin 100 mg/m2 on day 1 and capecitabine 800 mg/m2/day on days 1–7 every 14 days. Treatment was to be administered until disease progression or until withdrawal from the study due to unacceptable toxicity or other reasons. Results Eighteen patients were enrolled. The median age was 63 years (range, 39–73 years). Among these 18 patients, only one patient (5.5%) achieved an objective response. Therefore, the accrual terminated. The median time to disease progression was 2.1 months, and the median overall survival duration was 4.9 months. One-year overall survival rates were 35.3%. The most frequently reported grade 3 or 4 adverse events were asthenia (16.6%), and nausea (5.5%). There were no unexpected toxicities. Conclusions The addition of oxaliplatin and capecitabine to gemcitabine did not improve objective response in the first-line treatment of advanced pancreatic cancer patients.