Combination Gemcitabine and Docetaxel Therapy in Advanced Adenocarcinoma of the Pancreas

OBJECTIVE: To determine the clinical and laboratory response rate of a gemcitabine and docetaxel combination in human adenocarcinoma of the pancreas in vitro and in vivo. METHODS: Fifteen patients with unresectable pancreatic cancer were treated with gemcitabine, 900 mg/m(2), and docetaxel, 90 mg/m(2), every 3 weeks. Two human pancreatic cancer lines were tested in MTT assays for their response to titrations of gemcitabine and/or docetaxel at different time points and scheduling for biochemical synergy or additional antitumor effects. RESULTS: In vitro testing showed that these two agents were minimally effective alone but when combined, they displayed additional biochemical antiproliferative effects in MTT assays. With intent-to-treat analysis of all 15 patients, 4 patients (27%) achieved an objective response by CT scan, including one complete response. Seven patients (47%) had subjective improvement and decreased serum marker levels of CA 19-9. None of the 12 patients without prior therapy developed nadir white blood cell counts below 1,000/mm(3); 2 of 3 patients with prior radiation therapy developed nadir white blood cell counts below 1,000/mm(3). CONCLUSION: This regimen is well tolerated and appears to have a significant objective response rate. Gemcitabine and docetaxel antitumor effects are additive in vitro, which may help to explain the response rate.