Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

NCT ID: NCT00366457

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2011-07-31

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.

Conditions

Pancreatic Cancer; Adenocarcinoma of the Pancreas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine, Bevacizumab and Erlotinib

single-arm, no masking

Group Type: OTHER

Bevacizumab

Intervention Type: DRUG

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.

Erlotinib

Intervention Type: DRUG

Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.

Gemcitabine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

rhuMAb VEGF; Tarceva; Gemzar

Eligibility Criteria

Inclusion Criteria

• 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 </= 2.0
• Adequate hepatic function
• Adequate hematopoietic function
• Use of effective means of contraception in subjects of child-bearing potential

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lawrence S. Blaszkowsky, MD

Assistant Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence S. Blaszkowsky, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

05-234

Identifier Type: -

Identifier Source: org_study_id