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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date September 28, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
Progression-free survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
  • Overall survival
  • Tumor response
  • Adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
Official Title  ICMJE Phase II Multicenter Clinical Trial on Imatinib Treatment for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastrointestinal Stromal Tumor
  • Metastatic Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: imatinib mesylate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2016)
5
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
37
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764595
Other Study ID Numbers  ICMJE CDR0000615628
NIIGATAU-TRIGIST0805 ( Other Identifier: Niigata University Medical and Dental Hosptial )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study Sponsor  ICMJE Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators  ICMJE Niigata University Medical & Dental Hospital
Investigators  ICMJE
Principal Investigator: Tatsuo Kanda, MD Niigata University Medical & Dental Hospital
PRS Account Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP