Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed Duri… (NCT00265798) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate
United States38 participantsStarted 2005-09-14
Plain-language summary
This phase II trial is studying how well sorafenib works in treating patients with malignant gastrointestinal stromal tumor that progressed during or after previous treatment with imatinib mesylate and sunitinib malate. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed gastrointestinal stromal tumor
* Not amenable to curative surgery
* Kit-expressing tumor
* Disease progression (i.e., new lesion or 20% increase in unidimensional tumor size) on or after treatment with imatinib mesylate and sunitinib malate
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques OR \> 10 mm by spiral CT scan
* Only site of measurable disease must be outside of previously irradiated area
* No known brain metastases
* Performance status - ECOG 0-2
* More than 3 months
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Bilirubin normal
* AST and ALT \< 2.5 times upper limit of normal
* Creatinine ≤ 1.5 mg/dL
* Creatinine clearance \> 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No uncontrolled hypertension
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No evidence of bowel perforation or obstruction
* No prior angiogenesis inhibitors
* No imm…