Phase Ii Trial Of Capecitabine And Docetaxel As Second Line Therapy For Locally Advanced And Metastatic Pancreatic Cancer

15029 Background: Docetaxel and Capecitabine in combination are synergistic in preclinical models. The role of second line chemotherapy in pancreatic cancer is palliative and the role under investigation. Methods: Capecitabine 800 mg/m 2 PO bid on days 1–14 in combination with docetaxel 30 mg/m 2 IV on days 1 and 8 of each 21-day cycle were given to patients with advanced and metastatic pancreatic cancer previously treated with Gemcitabine. A 3-stage sequential design phase II trial was used with early stopping rules for efficacy at 13 and 26 enrolled patients Results: Twenty-four patients are evaluable for toxicity and evaluable for response. Thirteen are females and 11 male patients. Median age was 65 years. ECOG PS was as follows: PS 0: 2 patients; PS 1: 15 patients; PS 2: 5 patients. Three patients achieved a PR, with a RR of 12.5%. Stable disease for 2 or more cycles was observed in 70.8% of patients (n=17). 45 % (n=11) of patients had a 50% or more decrease in CA 19–9 levels. Treatment was well tolerated with no toxic deaths. Grade III and IV toxicities consisted of fatigue in 4 pts (17%); hand-foot syndrome in 4 patients (17%); diarrhea, anemia and mucositis in 2 patients (9%) and peripheral neuropathy in one patient (4%) Conclusions: The combination of capecitabine and docetaxel is active and well tolerated in pancreatic cancer previously treated with gemcitabine based-therapy. Enrollment continues. [Table: see text]