Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125021
Status:
COMPLETED
Last Update Posted:
2009-11-01
First Post:
2005-07-27
Brief Title:
Tarceva and Capecitabine for Pancreatic Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of OSI-774 Tarceva in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2009-10
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 phase II trial is designed to investigate the effectiveness of Tarceva OSI-774 combined with capecitabine in treating patients with metastatic pancreatic cancer
Detailed Description:
Patients will be treated once daily with Tarceva twice daily with capecitabine for 14 consecutive days followed by 7 days off of capecitabine a cycle is 21 days At week 1 of each cycle a physical exam and blood work will be performed Reassessment of tumor size will be conducted at 6 weeks 2 cycles 12 weeks 4 cycles and then every 9 weeks thereafter Patients will remain on treatment until one of the following occur disease progression illness that prevents further treatment or unacceptable adverse events
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