Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
Inclusion Criteria
Criteria:
- DISEASE CHARACTERISTICS:
- Histologically confirmed gastrointestinal stromal tumor
- Locally advanced disease: tumour size 〉5 cm and mitotic count 〉5/HPF;
tumour size 〉10 cm; mitotic count 〉10/HPF
- Potentially resectable disease: Multivisceral resection may be necessary to
get sufficient margins
- Documented c-kit (CD117) expression by immunohistochemical analysis of either
initial core specimen or, if recurrent disease, from original tumor block
- At least 1 site of measurable disease
- No known brain metastases
- PATIENT CHARACTERISTICS:
Age:18 and over Performance status:ECOG 0-3 Life expectancy:Not specified
- Platelet count > 100,000/mm3
- Absolute neutrophil count > 1,500/mm3 Hepatic
- AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic
metastases are present)
- Bilirubin < 1.5 times ULN
- No chronic active hepatitis
- No cirrhosis
- No other chronic liver disease Renal
- Creatinine < 1.5 times ULN
- No chronic renal disease Cardiovascular
- No New York Heart Association class III-IV cardiac disease
- No congestive heart failure
- No myocardial infarction within the past 6 months Immunology
- No active uncontrolled infection
- No known HIV positivity Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months
after completion of study treatment
- Must be medically fit to undergo surgery
- No other primary malignancy within the past 5 years except basal cell skin cancer,
carcinoma in situ of the cervix, or a primary malignancy that is not currently
clinically significant and does not require active intervention
- No gastrointestinal obstruction or major bleeding episode requiring immediate
surgical intervention
- No uncontrolled diabetes
- No other severe or uncontrolled medical disease
- No significant history of noncompliance to medical regimens
PRIOR CONCURRENT THERAPY:
- No concurrent anticancer biologic agents
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin)
unless disease is rapidly progressing
- No concurrent anticancer chemotherapy
- At least 28 days since prior radiotherapy
- More than 2 weeks since prior major surgery except tumor biopsy Other
- At least 28 days since prior investigational drugs
- At least 28 days since prior imatinib mesylate
- No concurrent therapeutic doses of warfarin
- Concurrent low-molecular weight heparin or mini-dose warfarin (1 mg per day)
prophylaxis is allowed