Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177242
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2005-09-12
Brief Title:
Study of Gefitinib and Docetaxel as Salvage Therapy in Advanced Pancreatic Carcinoma
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase II Study of Gefitinib and Docetaxel as Salvage Therapy in Advanced Pancreatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 59 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None