Gastrointestinal Stromal Tumor, Metastatic Cancer
Conditions
Keywords
gastrointestinal stromal tumor, liver metastases
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.
Interventions
DRUGimatinib 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.
Sponsors
Niigata University Medical & Dental Hospital
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 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 | 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 | 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. |
Countries
Japan
Outcome results
None listed