Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440167
Status:
UNKNOWN
Last Update Posted:
2012-07-09
First Post:
2007-02-22
Brief Title:
CapecitabineErlotinib Followed of Gemcitabine Versus GemcitabineErlotinib Followed of Capecitabine
Sponsor:
PD Dr med Volker Heinemann
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Randomized Phase III Trial With CapecitabineErlotinib Followed of Gemcitabine Versus GemcitabineErlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib It is the first trial of its kind to incorporate second-line treatment into the study design Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib The trial therefore not only compares two different regimens of first-line treatment it also compares two sequential treatment strategies
Detailed Description:
None
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