The multi-center trial was designed to evaluate the combination therapy in advanced pancreatic cancer patients who have not undergone chemotherapy. The study enrolled 39 patients with primary advanced pancreatic cancer. Patients received 1000mg/m2 gemcitabine every week for three out of four weeks with concurrent 1.5mg/m2 Orathecin given daily for five of the seven days each week. The cycle was repeated every four weeks until progression or patient withdrawal.
This protocol included a prospectively defined interim analysis (to be conducted after half of the patients had died) to estimate median survival. The analysis result is an estimated median survival of six months, with a Kaplan-Meier one year survival to be 27%.
Although the estimated one year survival is encouraging compared to similar studies in this indication, the study did not meet the pre-specified threshold for median survival in order to proceed to a phase III randomized study.
The study will remain closed to enrollment, but open for patient follow-up.