Phase 2 trial of oxaliplatin plus capecitabine (XELOX) as second‐line therapy for patients with advanced pancreatic cancer

BACKGROUND. To the authors' knowledge, there is no established second‐line chemotherapy for patients with pancreatic cancer who have received gemcitabine‐based therapy. A phase 2 trial was conducted to explore the efficacy of capecitabine and oxaliplatin (XELOX) in patients with advanced pancreatic cancer previously who were treated with gemcitabine. METHODS. Patients aged ≤65 years who had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 received oxaliplatin at a dose of 130 mg/m 2 given on Day 1 and capecitabine at a dose of 1000 mg/m 2 twice daily for 14 days. For patients aged >65 years or with an ECOG PS of 2, the oxaliplatin dose was 110 mg/m 2 on Day 1 and the capecitabine dose was 750 mg/m 2 twice daily for 14 days. The treatment was repeated every 3 weeks. Tumor measurements were performed every 9 weeks and the primary study objective was 6‐month overall survival. RESULTS. The study enrolled 41 patients. Of the 39 evaluable patients, 1 patient had a partial response and 10 patients demonstrated stable disease. The Kaplan‐Meier estimate of the overall median survival was 23 weeks (95% confidence interval [95% CI], 17.0‐31.0 weeks). Progression‐free survival was 9.9 weeks (95% CI, 9.6‐14.5 weeks). The 6‐month and 1‐year survival rates were 44% (95% CI, 31%‐62%) and 21% (95% CI, 11%‐38%), respectively. The most common grade 3‐4 nonhematologic toxicity was fatigue (toxicity was graded using the National Cancer Institute Common Toxicity Criteria [version 2.0]). CONCLUSIONS. The combination of capecitabine and oxaliplatin is active in gemcitabine‐pretreated patients with advanced pancreatic cancer, especially in patients with a good PS and those who have responded to first‐line chemotherapy. Cancer 2008. © 2008 American Cancer Society.