A phase II trial of imatinib mesylate in patients with metastatic pancreatic cancer.

OBJECTIVE

The aim of the study was to assess the clinical efficacy and toxicity of single-agent imatinib mesylate in patients with advanced, unresectable metastatic pancreatic cancer.

METHODS

Previously treated or untreated patients with histologically proven, unresectable pancreatic adenocarcinoma with adequate organ and bone marrow function were enrolled. Patients received imatinib 400 mg orally twice a day for a 28-day cycle. Response was evaluated every 4 weeks by imaging scans. Response was defined as lack of tumor progression at 3 months.

RESULTS

Eleven patients were enrolled, and 9 were evaluable for response. Best response was stable disease in 3 patients after 2 cycles of therapy. All of them subsequently progressed. No patients remained on treatment for 3 months or longer, which was the response end point. Median time to tumor progression was 47 days (range, 19-76 days) and median overall survival was 118 days (range, 40-221 days). The first 3 patients received imatinib 400 mg orally twice a day. Due to unexpected grades 2 and 3 toxicities, the dose was reduced to 600 mg daily which was well tolerated. Most common adverse events included grades 1 to 2 edema, liver enzyme elevations, nausea, and rash.

CONCLUSIONS

Single-agent imatinib does not have a significant activity in pancreatic cancer.