Cancer Clinical Trial
Official title:
Phase II Study of Gefitinib and Docetaxel as Salvage Therapy in Advanced Pancreatic Carcinoma
This is a phase II, open-label trial of Gefitinib and docetaxel in patients having one prior regimen of chemotherapy for with metastatic 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 and active. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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