Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366457
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2006-08-17
Brief Title:
Gemcitabine Bevacizumab and Erlotinib in Pancreatic Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase II Study of Gemcitabine Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2017-04
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:
The main purpose of this study is to learn whether or not the combination of gemcitabine bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer Bevacizumab is a new anti-cancer drug It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer
Detailed Description:
Participants will receive study treatment as an outpatient The study treatment will be given in time periods called cycles Each treatment cycle will be 28 days
Gemcitabine will be given intravenously on days 1 8 and 15 once per week for the first three weeks of the treatment cycle
Bevacizumab will be given intravenously on days 1 and 15 once every 2 weeks of the treatment cycle
Erlotinib will be taken orally every day of the treatment cycle
Participants will see the doctor or nurse practitioner every week for the first 28 days of treatment During all of the following cycles they will see the doctor or nurse practitioner on day 1 and day 15 of each cycle
Each 4-week cycle can be repeated until the participant or the doctor decided that they should be removed from the study
Gemcitabine will be given intravenously on days 1 8 and 15 once per week for the first three weeks of the treatment cycle
Bevacizumab will be given intravenously on days 1 and 15 once every 2 weeks of the treatment cycle
Erlotinib will be taken orally every day of the treatment cycle
Participants will see the doctor or nurse practitioner every week for the first 28 days of treatment During all of the following cycles they will see the doctor or nurse practitioner on day 1 and day 15 of each cycle
Each 4-week cycle can be repeated until the participant or the doctor decided that they should be removed from the study
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