Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
Gastrinoma, Glucagonoma, Insulinoma
About this trial
This is an interventional treatment trial for Gastrinoma
Eligibility Criteria
Criteria: Histologically confirmed neuroendocrine tumor: Carcinoid tumor OR islet cell carcinoma/other well-differentiated tumor No anaplastic or high-grade histology Metastatic disease Measurable disease No thyroid carcinoma of any histology, thymoma, or pheochromocytoma/paraganglioma No known brain metastases Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: At least 24 weeks Hematopoietic: Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 No bleeding diathesis Hepatic: Bilirubin =< 2 times upper limit of normal (ULN) Aspartate aminotransferase (AST) =< 3 times ULN (5 times ULN if liver metastases are present) International normalized ratio (INR) normal PTT normal Renal: Creatinine =< 1.5 times ULN Cardiovascular: No poorly controlled hypertension; No symptoms of congestive heart failure; No unstable angina pectoris; No cardiac arrhythmia Gastrointestinal: Able to swallow capsules intact No gastrointestinal tract disease resulting in an inability to take oral medication (e.g., dysphagia) No requirement for IV alimentation No active peptic ulcer disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other invasive malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other uncontrolled illness At least 4 weeks since prior interferon No more than 1 prior systemic chemotherapy regimen: Chemoembolization is not considered systemic chemotherapy At least 4 weeks since prior chemoembolization At least 3 weeks since prior radiotherapy No prior procedures adversely affecting intestinal absorption At least 4 weeks since prior hepatic artery embolization No other prior systemic therapy No other concurrent investigational treatment No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, or phenytoin) No concurrent rifampin No concurrent Hypericum perforatum (St. John's wort) Prior or concurrent octreotide for symptomatic treatment allowed No concurrent therapeutic anticoagulation: Concurrent prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices allowed provided requirements for INR or PTT are met At least 4 weeks since prior major surgery Recovered from all prior therapy
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A (patients with carcinoid tumors)
Group B (islet cell and other neuroendocrine tumors)
Patients receive 400 mg oral sorafenib twice daily on days 1-28.
Patients receive 400 mg oral sorafenib twice daily on days 1-28.