Status:
TERMINATED
Imatinib Mesylate With or Without Surgery in Treating Patients With Metastatic Gastrointestinal Stromal Tumor That is Responding to Imatinib Mesylate
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Gastrointestinal Stromal Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Surgery may remove residual disease in patients with gastrointestinal stromal tumor that is responding to imatinib mesylate. It is not yet known whether surgery is more effective than conti...
Detailed Description
OBJECTIVES: Primary * Evaluate whether surgery of residual disease improves the progression-free survival of patients with metastatic gastrointestinal stromal tumor responding to imatinib mesylate. ...
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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00956072
Start Date
May 1 2009
Last Update
September 24 2012
Active Locations (1)
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1
European Organization for Research and Treatment of Cancer
Naples, Italy, 80131