Phase
Condition
Sarcoma (Pediatric)
Stomach Cancer
Gastrointestinal Diseases And Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically confirmed gastrointestinal stromal tumor expressing CD117+ or with documented mutation of the KIT or PDGFRA gene
Metastatic disease (liver and/or abdominal cavity)
No extra-abdominal metastases
Measurable disease according to RECIST criteria
Achieved complete response, partial response, or stable disease without progression since the start of imatinib mesylate therapy, documented according to RECIST
Underwent 6-12 months of treatment with imatinib mesylate as a standard of care or within other clinical studies (surgery should be feasible before the end of the 12th month from imatinib mesylate onset)
Surgically resectable residual disease as assessed by CT scan and/or MRI within the past 14 days
PATIENT CHARACTERISTICS:
WHO performance status 0-1
ANC > 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin ≥ 9 g/dL
Creatinine < 120 μmol/L
Albumin > 25 g/L
Total bilirubin < 2 times upper limit of normal (ULN)
AST and ALT < 2.5 times ULN (< 5 ULN in case of liver metastases)
Alkaline phosphatase < 2.5 times ULN (< 5 ULN in case of bone or liver metastases)
Negative pregnancy test within the past 14 days
Fertile patients must use effective contraception
No uncontrolled hypertension (diastolic BP > 95 mm Hg and systolic BP > 170 mm Hg)
No myocardial infarction, unstable, or uncontrolled cardiac disease within the past 6 months
No history of arterial thrombosis or deep vein thrombosis within the past year
No bleeding diathesis, coagulopathy, or major bleeding within the past 6 months
No severe and/or uncontrolled concurrent medical disease, including any of the following conditions:
Diabetes
Chronic renal disease
Liver disease, including chronic viral hepatitis judged at risk of reactivation
Active infection, including HIV infection
No prior malignancy (other than in situ cervical cancer, in situ melanoma, or basal cell or squamous cell cancer of the skin) unless treated with curative intent and without evidence of disease for at least 3 years
No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior adjuvant or neo-adjuvant imatinib mesylate or other tyrosine kinase inhibitor
No coumadin-type anticoagulant > 2mg/day within the past 7 days
No major surgery within the past 28 days
No medication that interacts moderately or strongly with the CYP3A system within the past 14 days
Study Design
Study Description
Connect with a study center
European Organization for Research and Treatment of Cancer
Naples, 80131
ItalySite Not Available
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