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Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Lawrence S. Blaszkowsky, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00366457
First received: August 17, 2006
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Pancreatic Cancer Adenocarcinoma of the Pancreas Drug: Bevacizumab Drug: Erlotinib Drug: Gemcitabine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Lawrence S. Blaszkowsky, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Time to Tumor Progression [ Time Frame: all patients will be followed for a minimum of 4 months ]

    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 [ Time Frame: after at least one 28-day cycle of treatment ]
    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 [ Time Frame: during and after first 28-day cycle of treatment ]
    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 [ Time Frame: 5 years ]
    overall survival (OS) = time from study entry until death from any cause


Enrollment: 32
Study Start Date: August 2006
Study Completion Date: July 2011
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gemcitabine, Bevacizumab and Erlotinib
single-arm, no masking
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.
Other Name: rhuMAb VEGF
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.
Other Name: Tarceva
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.
Other Name: Gemzar

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366457

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Genentech, Inc.
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Lawrence S. Blaszkowsky, MD Massachusetts General Hospital
  More Information

Responsible Party: Lawrence S. Blaszkowsky, MD, Assistant Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00366457     History of Changes
Other Study ID Numbers: 05-234
Study First Received: August 17, 2006
Results First Received: February 14, 2017
Last Updated: April 7, 2017

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Erlotinib Hydrochloride
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 21, 2017