Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

Study Overview
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Brief Summary
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RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

Detailed Description
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OBJECTIVES: To evaluate the safety and efficacy of imatinib mesylate in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor. OUTLINE: This is a multicenter study. Patients receive oral imatinib mesylate daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Official Title
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Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)

Conditions
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Gastrointestinal Stromal Tumor, Metastatic Cancer

Intervention / Treatment
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* Drug: imatinib mesylate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of gastrointestinal stromal tumor (GIST) Hepatic metastasis meeting the following criteria: No more than 3 hepatic metastases Clinically diagnosed as surgically resectable with no macroscopic residual tumor Synchronous hepatic metastasis allowed provided primary tumor is also resectable No metastatic tumor that requires radiofrequency ablation and/or microwave coagulation therapy to control the disease No extrahepatic metastasis No history of GIST recurrence PATIENT CHARACTERISTICS: ECOG performance status 0-1 Leukocyte count ≥ 3,000/μL Neutrophil count ≥ 1,500/μL Hemoglobin ≥ 8.0 g/dL Platelet count ≥ 75,000/μL Total bilirubin ≤ 2.0 mg/dL ALT and AST < 120 IU/L GTP < 210 IU/L Not pregnant No poorly controlled diabetes mellitus No NYHA class III-IV cardiac function No hepatitis B or hepatitis B carriers No other malignancy requiring treatment PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior imatinib mesylate No prior interventional radiology for metastatic disease No other concurrent treatment, including surgery or radiotherapy, for metastatic lesions

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imatinib mesylate<br>All patients start imatinib mesylate as oral dose of 400 mg/d once daily after meal within 28 days after enrollment, and continue the treatment until 3 years after enrollment of the last patient. | Drug: imatinib mesylate<br>* Imatinib mesylate is administered as oral dose of 400 mg/d once daily after meal until 3 years after enrollment of the last patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival is defined as time from date of starting protocol treatment until date of comfirmation of progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 or death from any cause, whichever comes first. | 7.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Tumor response is defined as best overall response by RECIST v1.0 from date of starting protocol treatment until 48 weeks after starting protocol treatment. | 48 weeks | 
| Overall survival | Overall survival is defined as time from date of starting protocol treatment until date of death from any cause. | 7.5 years | 
| Types and severities of adverse events | Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center. | 7.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal stromal tumor, liver metastases