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Completed

NCT Number: NCT00366457

Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer

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.

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Key information

Conditions

Pancreatic Cancer Adenocarcinoma of the Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: rhuMAb VEGF

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.

Other names: Tarceva

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.

Other names: Gemzar

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. Overall Survival

    Time frame: 5 years

    overall survival (OS) = time from study entry until death from any cause

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2011
First posted
Aug 21, 2006
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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