Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Maisonneuve-Rosemont Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hippocrate Research & Development
Information provided by:
Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT00290485
First received: February 9, 2006
Last updated: April 6, 2006
Last verified: April 2006
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: Imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study on Preoperative Administration of Gleevec in Patients With Initially Non-Resectable Gastrointestinal Stromal Tumor

Resource links provided by NLM:


Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:
  • Patient response rate according to RECIST criteria

Secondary Outcome Measures:
  • 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 overall survival
  • Evaluate whether the response rate can predict survival

Estimated Enrollment: 50
Study Start Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00290485

Contacts
Contact: Pierre Dubé, MD (514) 252-3822 pierredube@videotron.qc.ca

Locations
Canada, Quebec
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, h1t 2m4
Contact: Pierre Dubé, MD    (514) 252-3822    pierredube@videotron.qc.ca   
Principal Investigator: Pierre Dubé, MD         
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Hippocrate Research & Development
Investigators
Study Chair: Pierre Dubé, MD Maisonneuve-Rosemont Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00290485     History of Changes
Obsolete Identifiers: NCT00363103
Other Study ID Numbers: Q-CTG-01-V7.0-A1
Study First Received: February 9, 2006
Last Updated: April 6, 2006
Health Authority: Canada: Health Canada

Keywords provided by Maisonneuve-Rosemont Hospital:
non-resectable tumor
high-risk tumor
metastasis
Response Evaluation Criteria in Solid Tumors (RECIST)
Gleevec
Imatinib mesylate

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014