Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

Study Overview

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.

* 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.

Pancreatic Cancer
Adenocarcinoma of the Pancreas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-08-17	Results First Submitted 2017-02-14	Last Update Submitted that met QC Criteria 2017-04-07
First Submitted that Met QC Criteria 2006-08-17	Results First Submitted that Met QC Criteria 2017-02-14	Last Update Posted (ACTUAL) 2017-05-15
First Posted (ACTUAL) 2006-08-21	Results First Posted 2017-03-31	Last Verified 2017-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Gemcitabine, Bevacizumab and Erlotinib single-arm, no masking	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.

Participant Group/Arm

Intervention/Treatment

OTHER: Gemcitabine, Bevacizumab and Erlotinib

single-arm, no masking

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.

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Previously untreated patients with unresectable or metastatic adenocarcinoma of the pancreas
ECOG Performance Status 0-2
18 years of age or older
Radiographically measurable disease
Expected survival of at least 4 months
Creatinine of
Adequate hepatic function
Adequate hematopoietic function
Use of effective means of contraception in subjects of child-bearing potential

Warfarin anticoagulation
Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor
Coexistent malignant disease
Current or recent (within 4 weeks) participation in a clinical trial
Pregnancy
Documented invasion of adjacent organs or major blood vessels
Blood pressure of > 150/100mmHg
Unstable angina
NYHA Grade II or greater congestive heart failure
History of myocardial infarction or stroke within 6 months
Clinically significant peripheral vascular disease
Evidence of bleeding diathesis of coagulopathy
Presence of CNS or brain metastases
Major surgical procedure, open biopsy, or significant traumatic event within 28 days
Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
Serious non-healing wound, ulcer or bone fracture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Genentech
Inc.
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute

Investigators

Principal investigator: Lawrence S. Blaszkowsky, MD, Massachusetts General Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications