Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

NCT00366457 | Completed Phase 2 Results DMC

• 1 other identifier: 05-234
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Pancreatic Cancer; Adenocarcinoma of the Pancreas

Outcome Measures

Primary Outcomes (1)

• Time to Tumor Progression

  Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  all patients will be followed for a minimum of 4 months

Secondary Outcomes (3)

• Response Rate

  after at least one 28-day cycle of treatment

• Toxicity Profile

  during and after first 28-day cycle of treatment

• Overall Survival

  5 years

Study Arms (1)

Gemcitabine, Bevacizumab and Erlotinib

OTHER

single-arm, no masking

Drug: Bevacizumab; Drug: Erlotinib; Drug: Gemcitabine

Interventions

Bevacizumab 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.

Also known as: rhuMAb VEGF

Gemcitabine, Bevacizumab and Erlotinib

Erlotinib DRUG

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

Also known as: Tarceva

Gemcitabine, Bevacizumab and Erlotinib

Gemcitabine 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.

Also known as: Gemzar

Gemcitabine, Bevacizumab and Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated patients with unresectable or metastatic adenocarcinoma of the pancreas
• ECOG Performance Status 0-2
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Genentech, Inc.: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bevacizumab; Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Lawrence S. Blaszkowsky, MD
• Organization: Massachusetts General Hospital

LBLASZKOWSKY@mgh.harvard.edu

6172191230

Study Officials

• Lawrence S. Blaszkowsky, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Physician

Study Record Dates

• First Submitted: August 17, 2006
• First Posted: August 21, 2006
• Study Start: August 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: July 1, 2011
• Last Updated: May 15, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-04

Locations

US (3)