Gleevec Administered Preoperatively to Reduce Gastrointestinal Stromal Tumor (GIST)

Sponsor

Maisonneuve-Rosemont Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00290485

Collaborator

Hippocrate Research & Development (Other)

Enrollment

Location

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors	Drug: Imatinib mesylate	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

when the surgical team considers that the risk of incomplete resection (R1 or R2) of a GIST is higher than 20%
when the resection of a GIST necessitates a highly morbid procedure
when a GIST is attached to 3 or more major intra-abdominal structures or to a major intra-abdominal blood vessel
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:

absolute neutrophil count < 1.5 E+09/L
platelet count < 80000 E+09/L
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.