Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST)

April 6, 2006 updated by: Maisonneuve-Rosemont Hospital

A Phase II Study on Preoperative Administration of Gleevec in Patients With Initially Non-Resectable Gastrointestinal Stromal Tumor

The aim of this study is to demonstrate that the use of Gleevec in initially non-resectable gastrointestinal stromal tumors can lead to allow complete resection in 20% of cases.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gastrointestinal stromal tumor (GIST) is a specific, immunohistochemically KIT+ mesenchymal neoplasm of the gastrointestinal tract. The identification of KIT+ tumor has become more important after introduction of target treatment with KIT tyrosine kinase inhibitor Imatinib mesylate (Gleevec). Despite this progress, GIST patients presenting a tumor larger than 5 cm have a 10 year survival between 10% and 30%. Indeed, the risk of microscopic spreading of the tumor during surgery is very high since intra-abdominal organs are in close relation to each others. To improve survival, it seemed logical to use preoperative Gleevec to reduce tumor size and improve efficacy of the surgical procedure.

Study Type

Interventional

Enrollment

50

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Maisonneuve-Rosemont Hospital
        • Contact:
        • Principal Investigator:
          • Pierre Dubé, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GIST patient considered initially non-resectable as defined by one of the following:

    1. when the surgical team considers that the risk of incomplete resection (R1 or R2) of a GIST is higher than 20%
    2. when the resection of a GIST necessitates a highly morbid procedure
    3. when a GIST is attached to 3 or more major intra-abdominal structures or to a major intra-abdominal blood vessel
    4. when GIST is considered at very high risk of recurrence. This is the case when it is a recurrence or when the tumor is in very close contact with a structure that cannot be resected by surgery or when the patient has metastasis.
  • Outpatient is 18 years old or more
  • ECOG performance status 0, 1 or 2
  • Immunohistochemical confirmation of KIT overexpression must exist at the study entry
  • Measurable disease on CT-Scan or MRI (ultrasound and/or operative finding are not acceptable) and response to RECIST criteria
  • Have a life expectancy of at least 6 months
  • Be willing and able to comply with the protocol (and surgery if required) for the duration of the study
  • Give written informed consent prior to study-specific screening procedure, with the understanding that the patient has the right to withdraw from the study at any time without prejudice

Exclusion Criteria:

  • received Imatinib in the past
  • received a full course of radiotherapy within 3 months of inclusion in the study. A short course of radiotherapy to control bleeding is allowed.
  • received systemic chemotherapy within 4 weeks of inclusion in the study
  • received steroids for less than 4 weeks of inclusion in the study
  • pregnant or lactating women
  • women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • sexually active males or females (of childbearing potential) unwilling to practice contraception during the study
  • history of other malignancy within the past 5 years, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  • clinical or other evidence of CNS metastases
  • myocardial infarction within the last 3 months
  • any medical condition that contraindicates potential surgery
  • lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication
  • any serious uncontrolled concomitant disease

  • any of the following laboratory values:

    1. absolute neutrophil count < 1.5 E+09/L
    2. platelet count < 80000 E+09/L
    3. AST or ALT higher than 2 X normal
  • major surgery within 4 weeks prior to start of study treatment, or lack of complete recovery from effects of major surgery
  • patients with known or suspected hypersensitivity to one of the Gleevec components.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient response rate according to RECIST criteria

Secondary Outcome Measures

Outcome Measure
Evaluate overall survival
Clinical response to treatment
Radiological response to treatment
Pathological response to treatment
Compare clinical with pathological response
Evaluate the impact of Gleevec on surgical morbidity
Evaluate disease-free survival
Evaluate whether the response rate can predict survival

Collaborators and Investigators

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

Sponsor

Maisonneuve-Rosemont Hospital

Collaborators

Hippocrate Research & Development

Investigators

  • Study Chair: Pierre Dubé, MD, Maisonneuve-Rosemont Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2005

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 13, 2006

Study Record Updates

Last Update Posted (Estimate)

April 7, 2006

Last Update Submitted That Met QC Criteria

April 6, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q-CTG-01-V7.0-A1

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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