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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

October 1, 2008
September 27, 2016
October 2008
March 2016   (final data collection date for primary outcome measure)
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.
Progression-free survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00764595 on ClinicalTrials.gov Archive Site
  • 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.
  • Overall survival [ Designated as safety issue: No ]
  • Tumor response [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastrointestinal Stromal Tumor
  • Metastatic Cancer
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00764595
CDR0000615628, NIIGATAU-TRIGIST0805
Yes
Not Provided
Not Provided
Translational Research Informatics Center, Kobe, Hyogo, Japan
Translational Research Informatics Center, Kobe, Hyogo, Japan
Niigata University Medical & Dental Hospital
Principal Investigator: Tatsuo Kanda, MD Niigata University Medical & Dental Hospital
Translational Research Informatics Center, Kobe, Hyogo, Japan
September 2016

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