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Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

Primary Purpose

Pancreatic Cancer, Adenocarcinoma of the Pancreas

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Erlotinib
Gemcitabine
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Gemcitabine, Bevacizumab and Erlotinib

Arm Description

single-arm, no masking

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Response Rate
Response rate using RECIST criteria and latest time point available. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Toxicity Profile
Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening
Overall Survival
overall survival (OS) = time from study entry until death from any cause

Full Information

First Posted
August 17, 2006
Last Updated
April 7, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Genentech, Inc., Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00366457
Brief Title
Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Official Title
Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Genentech, Inc., Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Adenocarcinoma of the Pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine, Bevacizumab and Erlotinib
Arm Type
Other
Arm Description
single-arm, no masking
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
rhuMAb VEGF
Intervention Description
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
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
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
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Tumor Progression
Description
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.
Time Frame
all patients will be followed for a minimum of 4 months
Secondary Outcome Measure Information:
Title
Response Rate
Description
Response rate using RECIST criteria and latest time point available. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
after at least one 28-day cycle of treatment
Title
Toxicity Profile
Description
Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening
Time Frame
during and after first 28-day cycle of treatment
Title
Overall Survival
Description
overall survival (OS) = time from study entry until death from any cause
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence S. Blaszkowsky, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

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