NCT00366457

Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Adenocarcinoma of the Pancreas

Interventions

Type	Name	Description
DRUG	Bevacizumab	Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
DRUG	Erlotinib	Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
DRUG	Gemcitabine	Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-08-01
• Completion: 2011-07-01
• First posted: 2006-08-21
• Last updated: 2017-05-15
• Results posted: 2017-03-31

Locations

3 sites across 1 country: United States