Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

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