A phase II study of docetaxel in combination with ZD1839 (gefitinib) in previously treated patients with metastatic pancreatic cancer

15080 Background: The reported activity of docetaxel in pancreatic cancer and high level of EGFR expression in pancreatic carcinomas led us to examine the efficacy of combination docetaxel and gefitinib in patients with metastatic pancreatic cancer. Methods: Eligibility criteria included PS = 1, failed prior adjuvant ot metastatic gemcitabine-containing regimen, = 1 prior regimen for metastatic disease, no prior taxane or EGFR inhibitor, and adequate organ function. Patients received docetaxel 40 mg/m2 intravenously weekly for 2 of every 3 weeks and daily oral gefitinib 250 mg. The primary endpoint was CA19–9 response (>50% decrease in tumor marker CA19–9 levels). Additional endpoints included radiologic response, toxicity, and survival. Results: Fifteen patients received docetaxel and gefitinib between 11/2/04 and 11/26/05. The median age of patients was 60 (46–76), and included 7 women and 8 men. The regimen was generally well tolerated, and there were no unanticipated toxicities. Grade 3 or 4 toxicities included lymphopenia (6 pts), hyperglycemia (3 pts), leucopenia (3 pts), infection (2 pts), fatigue (2 pts), elevated transaminases (2 pts), neutropenia (2 pts), pleural effusion (2 pts), irregular menses (1 pt), anorexia (1 pt), dysphagia/esophagitis (1 pt), diarrhea (1 pt), alkaline phosphatase (1 pt), and sensory neuropathy (1 pt). No treatment-related deaths occurred. No patient experienced a biochemical (CA 19–9) response to treatment. All 15 patients were evaluable for radiologic response, of which 9 experienced stable disease and 6 progressive disease as their best response to therapy. The trial was stopped due to lack of efficacy, in accordance with an early stopping rule incorporated into the trial design. Conclusions: In the doses and schedule used in this trial, the combination of docetaxel and gefitinib does not appear to be active in patients with pancreatic cancer who have failed prior gemcitabine-based chemotherapy. No significant financial relationships to disclose.