A phase II study of weekly irinotecan as first-line therapy for patients with metastatic pancreatic cancer.

Purpose: The aim of this study was to assess the efficacy and toxicity of weekly irinotecan in patients with metastatic pancreatic cancer.

Patients And Methods: Patients with histologically proven pancreatic adenocarcinoma, at least one bidimensionally measurable metastatic lesion, and no prior chemotherapy were selected. Irinotecan at a dose of 100 mg/m2 was administered intravenously for 90 min on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity. Pharmacokinetics was examined on day 1 of the first cycle of treatment.

Results: Thirty-seven of 40 enrolled patients were assessable for efficacy and toxicity. A partial response was obtained in 10 patients, giving an overall response rate of 27.0% (95% confidence interval 13.8-44.1%). The median overall survival was 7.3 months with a 1-year survival rate of 29.5%. Although toxicities were generally tolerated, one patient died of disseminated intravascular coagulation syndrome induced by neutropenia with watery diarrhea. Pharmacokinetic study showed that patients with biliary drainage seemed to have higher area under the concentration versus time curve for irinotecan and its metabolites compared with patients without biliary drainage.

Conclusion: Single-agent irinotecan has significant efficacy for metastatic pancreatic cancer. The toxicity with this schedule appears manageable, though it must be monitored carefully.