Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
Condition: Gastrinoma; Glucagonoma; Insulinoma; Metastatic Gastrointestinal Carcinoid Tumor; Neuroendocrine Tumor; Pancreatic Polypeptide Tumor; Recurrent Gastrointestinal Carcinoid Tumor; Recurrent Islet Cell Carcinoma; Somatostatinoma; WDHA Syndrome
MeSH terms: Neoplasms; Neuroendocrine Tumors; Carcinoid Tumor; Malignant Carcinoid Syndrome; Gastrointestinal Neoplasms; Insulinoma; Carcinoma, Islet Cell; Gastrinoma; Glucagonoma; Somatostatinoma; Vipoma; Recurrence
Intervention: sorafenib tosylate
Intervention description: 400 mg given orally
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well sorafenib tosylate works in treating patients with
      progressive metastatic neuroendocrine tumors. Sorafenib tosylate 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.
    

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