Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-28 @ 8:23 PM
Study NCT ID:
NCT00366457
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2006-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Sponsor:
Massachusetts General Hospital
Organization:
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:
True
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?: