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

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ClinicalTrials.gov Identifier: NCT00764595
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : September 28, 2016
Sponsor:
Collaborator:
Niigata University Medical & Dental Hospital
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor Metastatic Cancer Drug: imatinib mesylate Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : October 2008
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 7.5 years ]
    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 :
  1. Tumor response [ Time Frame: 48 weeks ]
    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.

  2. Overall survival [ Time Frame: 7.5 years ]
    Overall survival is defined as time from date of starting protocol treatment until date of death from any cause.

  3. Types and severities of adverse events [ Time Frame: 7.5 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764595


Locations
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Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Niigata University Medical & Dental Hospital
Investigators
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Principal Investigator: Tatsuo Kanda, MD Niigata University Medical & Dental Hospital
More Information
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Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00764595    
Other Study ID Numbers: CDR0000615628
NIIGATAU-TRIGIST0805 ( Other Identifier: Niigata University Medical and Dental Hosptial )
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
gastrointestinal stromal tumor
liver metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Gastrointestinal Stromal Tumors
Neoplasms
Neoplastic Processes
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