Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate

Running, not enrolling · Phase 2

Conditions studied: Gastrointestinal Stromal Tumor

In brief

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.

Key facts

Study ID

NCT00265798

Run by

National Cancer Institute (NCI)

People needed

38

Starts

2005-09-14

Expected to finish

2027-03-31

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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