QS104. A Pilot Study of Perillyl Alcohol in Pancreatic Cancer

Abstract

Chemotherapy has been unsuccessful in pancreatic cancer. Measurement of cell specific biological endpoints may clarify the evaluation of a newer generation of compounds. Perillyl alcohol (POH) has shown chemotherapeutic activity in pre-clinical systems through enhancing apoptosis. Objective: To assess the biological activity of POH in patients with resectable pancreatic cancer. Methods: Apoptosis was quantified with ApopTag in situ, Bak staining, and light microscopy. Tumor size, serum CA 19-9 level, and survival were also measured. Results: Eight patients enrolled. Toxicity was mild and POH was generally well tolerated. Tumor size and CA 19-9 level were unchanged with POH treatment. Survival time was longer in patients who received 100% of POH treatment (288 + 32 days) compared to those who did not (204 + 96 days), but this result did not achieve statistical significance (p= 0.2). There was a trend toward greater apoptosis in patients receiving POH compared to fresh operative controls; there was also a suggestion of greater apoptosis in tumor compared to normal pancreatic tissue in the same patient. Conclusions: Pancreatic cancer continues to be a deadly cancer. Incorporation of cell specific biological endpoints is challenging but feasible and should be employed in clinical studies of pancreatic cancer treatment. Our pilot study suggests that POH may indeed have effects on biologic endpoints. The study is underpowered, but will serve as a useful template for examining cell specific biologic endpoints in the testing of future agents that are thought to induce apoptosis in pancreatic cancer.