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

This study has been completed.
Sponsor:
Collaborator:
Niigata University Medical & Dental Hospital
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00764595
First received: October 1, 2008
Last updated: September 27, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Metastatic Cancer
Drug: imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 7.5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Tumor response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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.

  • Overall survival [ Time Frame: 7.5 years ] [ Designated as safety issue: No ]
    Overall survival is defined as time from date of starting protocol treatment until date of death from any cause.

  • Types and severities of adverse events [ Time Frame: 7.5 years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 5
Study Start Date: October 2008
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: imatinib mesylate
Imatinib mesylate is administered as oral dose of 400 mg/d once daily after meal until 3 years after enrollment of the last patient.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00764595

Locations
Japan
Aichi Cancer Center
Nagoya, Aichi, Japan, 464-8681
Aichi Medical University
Nagoya, Aichi, Japan, 480-1195
Hirosaki University, School of Medicine
Hirosaki, Aomori, Japan, 036-8562
National Hospital Organization Kure Medical Center
Kure, Hiroshima, Japan, 737-0023
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-0815
International Goodwill Hospital
Yokohama, Kanagawa, Japan, 245-0006
Kochi Medical School
Nankoku, Kochi, Japan, 783-8505
Kyoto Second Red Cross Hospital
Kanigyou-ku, Kyoto, Japan, 602-8026
University of Miyazaki Hospital
Kiyotake, Miyazaki, Japan, 889-1692
Niigata Prefectural Central Hospital
Joetsu, Niigata, Japan, 943-0192
Nagaoka Chuo General Hospital
Nagaoka, Niigata, Japan, 940-8653
Oita University Hospital
Yufu, Oita, Japan, 879-5593
Kawasaki Medical School
Kurashiki, Okayama, Japan, 701-01
Ryukyu University Hospital
Nishiharacho, Okinawa, Japan, 903-0215
Sakai Municipal Hospital
Sakai, Osaka, Japan, 590-0064
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Toyonaka Municipal Hospital
Toyonaka, Osaka, Japan, 560-8565
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan, 350-1241
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, Japan, 431-3192
University of Yamanashi Hospital
Chuo, Yamanashi, Japan, 409-3898
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Kagoshima University
Kagoshima, Japan, 890-8520
Kimitsu Chuo Hospital
Kisarazu-city, Japan, 292-8535
Kochi Health Sciences Center
Kochi, Japan, 781-8555
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Niigata University Medical and Dental Hospital
Niigata, Japan, 951-8510
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Okayama University Hospital
Okayama, Japan, 700-8558
Juntendo University Shizuoka Hospital
Shizuoka, Japan, 410-2295
Shizuoka Cancer Center
Shizuoka, Japan, 411-8777
Tokushima University Hospital
Tokushima, Japan, 770-8503
Tokyo Metropolitan - Komagome Hospital
Tokyo, Japan, 113-0021
Keio University Hospital
Tokyo, Japan, 160-8582
Toyama University Hospital
Toyama, Japan, 930-0194
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Niigata University Medical & Dental Hospital
Investigators
Principal Investigator: Tatsuo Kanda, MD Niigata University Medical & Dental Hospital
  More Information

Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00764595     History of Changes
Other Study ID Numbers: CDR0000615628  NIIGATAU-TRIGIST0805 
Study First Received: October 1, 2008
Last Updated: September 27, 2016
Health Authority: Japan: Translational Research Informatics Center Ethical Committiee

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
gastrointestinal stromal tumor
liver metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Gastrointestinal Stromal Tumors
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016