Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366457
• Other study ID #: 05-234
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2006
• Last updated: April 25, 2012
• Start date: August 2006
• Est. completion date: July 2011

Study information

• Verified date: April 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2011
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Pancreas
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the time to tumor progression on the combination of gemcitabine with bevacizumab and erlotinib.		TBD	No
Secondary	Determine the response rate and toxicity profile		TBD	Yes
Secondary	determine the median survival, 1 year survival, progression free survival and duration of response.		TBD	No