Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Adenocarcinoma of the Pancreas; Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: Bevacizumab; Drug: Erlotinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00366457

05-234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Gemcitabine, Bevacizumab and Erlotinib

Other group

Description:

single-arm, no masking

Treatment:

Drug: Erlotinib

Drug: Bevacizumab

Drug: Gemcitabine