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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Gefitinib and Docetaxel as Salvage Therapy in Advanced Pancreatic Carcinoma|
- Ascertain the median survival of advanced pancreatic cancer patients treated with Gefitinib and docetaxel.
- Determine the response rate, time to disease progression, survival rate at 6- month intervals after treatment start, and safety profile of Gefitinib and docetaxel as treatment for advanced pancreatic cancer
- Determine the time course of serial CA19-9 measurements during treatment.
|Study Start Date:||September 2004|
|Study Completion Date:||December 2006|
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.
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Kenneth Foon, MD||University of Pittsburgh|