Phase II Study of Gefitinib and Docetaxel as Salvage Therapy in Advanced Pancreatic Carcinoma
Initial therapy for metastatic pancreatic carcinoma is inadequate, and there is no effective
second line therapy. Docetaxel has known single agent activity in pancreatic carcinoma,
resulting in a median survival of 5.9 months, similar to gemcitabine, when assessed in Phase
II studies (10) and pancreatic tumors are known to express EGFR. We propose that the
combination of docetaxel with Gefitinib will have activity against pancreatic carcinoma,
whether the regimen is administered as first or second-line therapy for metastatic disease.
Given the toxicity profiles of both agents, we believe this will be a well-tolerated
regimen. In fact, preliminary analysis of a phase II study of docetaxel and Gefitinib with
an identical regimen in non-small cell lung cancer patients showed this regimen to be safe
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ascertain the median survival of advanced pancreatic cancer patients treated with Gefitinib and docetaxel.
Kenneth Foon, MD
University of Pittsburgh
United States: Food and Drug Administration
|University of Pittsburgh Medical Center||Pittsburgh, Pennsylvania 15213|