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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Imatinib mesylate is administered as oral dose of 400 mg/d once daily after meal until 3 years after enrollment of the last patient.
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.
Time frame: 7.5 years
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.
Time frame: 48 weeks
Overall survival
Overall survival is defined as time from date of starting protocol treatment until date of death from any cause.
Time frame: 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.
Time frame: 7.5 years
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Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Aichi Medical University
Nagoya, Aichi-ken, Japan
Hirosaki University, School of Medicine
Hirosaki, Aomori, Japan
National Hospital Organization Kure Medical Center
Kure, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
International Goodwill Hospital
Yokohama, Kanagawa, Japan
Kochi Medical School
Nankoku, Kochi, Japan
Kyoto Second Red Cross Hospital
Kanigyou-ku, Kyoto, Japan
University of Miyazaki Hospital
Kiyotake, Miyazaki, Japan
...and 26 more locations