A Phase II study of gemcitabine and docetaxel in patients with metastatic pancreatic carcinoma

Abstract

BACKGROUND Patients with metastatic pancreatic carcinoma have a poor survival. Chemotherapy with gemcitabine is the standard first‐line treatment. In a Phase II trial at one academic cancer center, the clinical safety and activity of combining gemcitabine and docetaxel were assessed. METHODS Patients with previously untreated, advanced pancreatic carcinoma were eligible. Bidimensionally measurable disease or evaluable disease with an elevated tumor marker, good performance status, and adequate organ function were required. Patients received docetaxel 60 mg/m² on Day 1 and gemcitabine 600 mg/m² on Days 1, 8, and 15 every 28 days. Ciprofloxacin was administered on Days 8–18. Dose attenuations were made as indicated for toxicity. Patients were restaged radiographically after every two cycles. RESULTS Thirty‐four patients were enrolled, and 33 patients were evaluable for response. There were 23 men and 10 women among the evaluable patients. The median age was 63 years, and all patients had an Eastern Cooperative Oncology Group performance status of 0 or 1. Three patients had received prior chemoradiation for postresection adjuvant therapy. One hundred forty‐six cycles of chemotherapy were administered, and 5 cycles (3%) in 4 patients (12%) were complicated by febrile neutropenia. Twenty percent and 11% of patients on Day 8 and Day 15 doses of gemcitabine, respectively, were omitted for toxicity. The objective response rate was 18%, and the median survival was 8.9 months (95% confidence interval, 5.2–11.2 months). The 1‐year survival rate was 29%. CONCLUSIONS The combination of gemcitabine and docetaxel in patients with advanced pancreatic carcinoma is well tolerated and is associated with moderate activity despite aggressive dose reduction. Whether combination regimens are more effective than single agents in the treatment of patients with pancreatic carcinoma awaits evaluation in randomized studies. Cancer 2002;94:97–103. © 2002 American Cancer Society.