Phase II trial of erlotinib plus capecitabine as first-line treatment for metastatic pancreatic cancer (XELTA study).

Aim: To evaluate the efficacy and safety of erlotinib plus capecitabine for metastatic pancreatic cancer.
Patients and Methods: This was a multicenter, uncontrolled, phase II trial. Patients with untreated metastatic pancreatic cancer received oral capecitabine at 1,000 mg/m(2) twice daily on days 1-14, of a 21-day treatment cycle; and oral erlotinib at 150 mg daily.
Results: Thirty-two patients were enrolled. The overall response rate (ORR) was 6%, with a median time to treatment failure of 2.1 months. The median follow-up was 7.6 months. The median progression-free survival was 2.1 months and median overall survival was 4.3 months. The one-year survival rate was 22%. Major grade 1 and 2 non-hematological toxicities were skin rash (34%), asthenia (31%) and diarrhea (31%). Grade 3 hematological toxicity was <13%. No grade 4 toxicities were detected. None of the patients died due to treatment toxicity.
Conclusion: The combination of capecitabine with erlotinib is an active regimen with a favorable safety profile for patients with metastatic pancreatic cancer.