Avastin and Tarceva for Upper Gastrointestinal Cancers

July 14, 2009 updated by: Rigshospitalet, Denmark

A Phase II Study of Erlotinib and Bevacizumab in Patients With Advanced Upper Gastrointestinal Carcinomas, Refractory or Intolerable to Standard Systemic Therapy

Erlotinib and bevacizumab have shown activity individually, as single drugs, or in combination with chemotherapy in upper gastro-intestinal cancers, including esophageal and gastro-esophageal adenocarcinomas, gastric cancer and pancreatic cancer. Biomarkers indicating an important role of EGF and VEGF have been found in these tumors, and in cholangiocarcinomas as well. There is promise that combined treatment with erlotinib and bevacizumab is active and tolerable in a broad range of upper gastro-intestinal cancers, justifying an experimental phase II-study of patients with these diagnoses, refractory or intolerant to standard systemic therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objective

  • To determine the median time to progression (TTP) and response rate (RR) of the combination of erlotinib and bevacizumab in patients with advanced upper gastro-intestinal carcinomas, refractory or intolerant to standard systemic therapy.

Secondary Objective

  • To determine safety, tolerability and toxicity.
  • To determine median and overall survival (OS).
  • To correlate efficacy of treatment with the expression of tumor markers obtained in serum (EFGR, bFGF, p-VEGF-A, and sVEGF-R2), in paraffin embedded tumor tissue (micro vessel density (MVD), and expression of VEGFR and EGFR, after immunostaining), and in fresh frozen tumor biopsies (micro array-based analyses of patterns of gene expression).

Treatment:

Bevacizumab (AvastinÒ) will be given intravenously at 10 mg/kg every other week.

Erlotinib is given as an orally daily dose and most be taken at least one hour before or two hours after ingestion of food.

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Århus, Denmark, 8000 C
        • Århus Sygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically verified carcinoma of the gall bladder or bile ducts.
  • PS 0-1 (ECOG scale)
  • Age > 18 years
  • Life expectancy > 3 months

  • Sufficient organ function, defined as:

    • Platelets > 100 x 109/liter
    • Leukocytes > 3,0 x 109/liter
    • ACN > 1,5 x 109/liter
    • ASAT and/or ALAT < 3 x upper normal limit
    • Bilirubin < 1,5 x upper normal limit
    • EDTA clearance > 45 ml/min
    • APTT and INR < normal limit
  • Fertile females must use oral contraceptive, IUD (intrauterine device) or preservatives. Fertile males must use preservatives.

Exclusion Criteria:

  • Radiotherapy or chemotherapy within the last 4 weeks
  • Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
  • Any prior EGFR- or VEGFR-based therapy
  • Any condition (medical, social, psychological), which would prevent adequate information and follow-up
  • Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding
  • Any other active malignancy, except basal or squamous cell carcinoma of the skin, or carcinoma in situ
  • Any significant cardiac disease (New York Heart Association Class II or greater), significant arrythmia, congestive heart failure, acute myocardial infarction within 6 months or unstable angina pectoris
  • Clinically significant peripheral vascular disease
  • Evidence of coagulopathy
  • Use of ASA, NSAIDs or clopidogrel

  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, anticipation of need for major surgical procedure during the curse of the study

    o Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to treatment

  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 month prior to treatment
  • Any ongoing infection, uncontrolled diabetes mellitus, serious non-healing wound or ulcer
  • Pregnancy or breast feeding
  • Ongoing therapeutic anti-coagulation
  • Hypertension with blood pressure > 150/100 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erlotinib and bevacizumab
Drug: Erlotinib and bevacizumab
Erlotonib 150 mg daily bevacizumab 10 mg/kg every 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: 1 year
1 year
Objective response by RECIST criteria
Time Frame: From time of treatment start to response evaluation
From time of treatment start to response evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 1 year
1 year
Toxicity evaluated by NCI-CTCae version 3.0
Time Frame: 1 year
1 year
Biomarkers
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

July 10, 2006

First Submitted That Met QC Criteria

July 10, 2006

First Posted (Estimate)

July 11, 2006

Study Record Updates

Last Update Posted (Estimate)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EB-UGI-01
  • 2006-001308-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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