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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: October 1, 2008
Last updated: September 19, 2013
Last verified: July 2009

October 1, 2008
September 19, 2013
October 2008
September 2014   (final data collection date for primary outcome measure)
Progression-free survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764595 on Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Tumor response [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
Same as current
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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.


  • 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.

Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Gastrointestinal Stromal Tumor
  • Metastatic Cancer
Drug: imatinib mesylate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Not Provided
September 2014   (final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
20 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Niigata University Medical & Dental Hospital
Not Provided
Principal Investigator: Tatsuo Kanda, MD Niigata University Medical & Dental Hospital
National Cancer Institute (NCI)
July 2009

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