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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase: Completed; Phase 2

Conditions: Metastatic Cancer; Gastrointestinal Stromal Tumor

Treatments: Drug: imatinib mesylate

Study type: Interventional

Funder types: Other

Identifiers

NCT00764595

NIIGATAU-TRIGIST0805 (Other Identifier)

CDR0000615628

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

imatinib mesylate

Experimental group

Description:

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.

Treatment:

Drug: imatinib mesylate