- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00764595
Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor (GISTs)
Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
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Kagoshima, Japan, 890-8520
- Kagoshima University
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Kisarazu-city, Japan, 292-8535
- Kimitsu Chuo Hospital
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Kochi, Japan, 781-8555
- Kochi Health Sciences Center
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Kumamoto, Japan, 860-8556
- Kumamoto University Hospital
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Niigata, Japan, 951-8566
- NIigata Cancer Center Hospital
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Niigata, Japan, 951-8510
- Niigata University Medical and Dental Hospital
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Shizuoka, Japan, 410-2295
- Juntendo University Shizuoka Hospital
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Tokushima, Japan, 770-8503
- Tokushima University Hospital
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Tokyo, Japan, 160-8582
- Keio University Hospital
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Tokyo, Japan, 113-0021
- Tokyo Metropolitan - Komagome Hospital
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Toyama, Japan, 930-0194
- Toyama University Hospital
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Aichi
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Nagoya, Aichi, Japan, 464-8681
- Aichi Cancer Center
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Nagoya, Aichi, Japan, 480-1195
- Aichi Medical University
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Aomori
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Hirosaki, Aomori, Japan, 036-8562
- Hirosaki University, School of Medicine
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Hiroshima
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Kure, Hiroshima, Japan, 737-0023
- National Hospital Organization Kure Medical Center
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-0815
- Kanagawa Cancer Center
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Yokohama, Kanagawa, Japan, 245-0006
- International Goodwill Hospital
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Kochi
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Nankoku, Kochi, Japan, 783-8505
- Kochi Medical School
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Kyoto
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Kanigyou-ku, Kyoto, Japan, 602-8026
- Kyoto Second Red Cross Hospital
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Miyazaki
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Kiyotake, Miyazaki, Japan, 889-1692
- University of Miyazaki Hospital
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Niigata
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Joetsu, Niigata, Japan, 943-0192
- Niigata Prefectural Central Hospital
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Nagaoka, Niigata, Japan, 940-8653
- Nagaoka Chuo General Hospital
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Oita
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Yufu, Oita, Japan, 879-5593
- Oita University Hospital
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Okayama
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Kurashiki, Okayama, Japan, 701-01
- Kawasaki Medical School
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Okinawa
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Nishiharacho, Okinawa, Japan, 903-0215
- Ryukyu University Hospital
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Osaka
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Sakai, Osaka, Japan, 590-0064
- Sakai Municipal Hospital
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Suita, Osaka, Japan, 565-0871
- Osaka University Hospital
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Toyonaka, Osaka, Japan, 560-8565
- Toyonaka Municipal Hospital
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Saitama
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Hidaka, Saitama, Japan, 350-1241
- Saitama Medical University International Medical Center
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 431-3192
- Hamamatsu University School of Medicine
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Yamanashi
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Chuo, Yamanashi, Japan, 409-3898
- University of Yamanashi Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: imatinib mesylate
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.
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Imatinib mesylate is administered as oral dose of 400 mg/d once daily after meal until 3 years after enrollment of the last patient.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 7.5 years
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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.
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7.5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Types and severities of adverse events
Time Frame: 7.5 years
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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.
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7.5 years
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Tumor response
Time Frame: 48 weeks
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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.
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48 weeks
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Overall survival
Time Frame: 7.5 years
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Overall survival is defined as time from date of starting protocol treatment until date of death from any cause.
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7.5 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tatsuo Kanda, MD, Niigata University Medical & Dental Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Neoplastic Processes
- Neoplasms, Connective Tissue
- Neoplasm Metastasis
- Gastrointestinal Stromal Tumors
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- CDR0000615628
- NIIGATAU-TRIGIST0805 (Other Identifier: Niigata University Medical and Dental Hosptial)
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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