• Overall survival [ Time Frame: approximately 12 months per patient ] [ Designated as safety issue: Yes ]
• Duration of response [ Time Frame: approximately 12 months per patient ] [ Designated as safety issue: Yes ]
• Objective radiographic response rate [ Time Frame: approximately 12 months per patient ] [ Designated as safety issue: Yes ]
• Biochemical response rate (>50% reduction in tumor marker) [ Time Frame: approximately 12 months per patient ] [ Designated as safety issue: Yes ]
• Treatment toxicity [ Time Frame: approximately 12 months per patient ] [ Designated as safety issue: Yes ]

• Overall survival
• Duration of response
• Objective radiographic response rate
• Biochemical response rate (>50% reduction in tumor marker)
• Treatment toxicity

This is a Phase II study consisting of 1-3 selective hepatic artery embolizations at approximately 5-week intervals, based on the extent of hepatic involvement with the tumor. Sunitinib malate (Sutent) will be administered on days 1-28 of a 42 day cycle. We believe that Sutent following embolization will significantly improve the duration of your response to treatment. Sutent treatment will be continued until disease progression, or excessive toxicity, or a maximum of eight cycles, whichever duration is shorter.

This is a single-center, open-label, non-randomized, prospective phase II trial. The treatment will consist of 1-3 selective hepatic artery embolizations at approximately 5-week intervals, based upon the extent of hepatic involvement with the tumor. Sunitinib malate (Sutent) will be administered daily on days 1-28 of a 42 day cycle. Subsequent embolizations (if necessary) will be scheduled during scheduled Sutent treatment breaks.

A visit will be required before the beginning of every 6-week cycle for physical examination (including blood work) and toxicity assessment. A CT or MRI scan of the abdomen (as well as any other relevant body part with metastases) will be obtained prior to the second cycle and every other cycle there after (prior to cycle 2, 4, 6 and 8).

Sutent treatment will be continued until disease progression, or excessive toxicity, or a maximum of eight cycles, whichever duration is shorter. Patients will undergo one final CT or MRI scan along with a follow-up visit 3 months after initiating the last cycle.

• Neuroendocrine Tumor
• Islet Cell Tumor

• Drug: Sunitinib malate
• Procedure: Hepatic Artery Embolizations

Inclusion Criteria:

• Well-differentiated metastatic carcinoid tumors and pancreatic endocrine tumors with measurable liver metastases.
• Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade less than or equal to 1.

• Adequate organ function as defined by the following criteria:

  1. AST; SGOT; ALT; SGPT less than or equal to 2.5 x local laboratory ULN, or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
  2. Total serum bilirubin less than or equal to 1.5 x ULN
  3. Absolute neutrophil count (ANC) greater than or equal to 1500/microL
  4. Platelets greater than or equal to 100,000/microL
  5. Hemoglobin greater than or equal to 9.0 g/dL
  6. Serum calcium less than or equal to 12.0 mg/dL
  7. Serum creatinine less than or equal to 1.5 x ULN
  8. Prothrombin and activated partial thromboplastin time (PT and aPTT) less than or equal to 1.5 x ULN
• ECOG Performance Status less than or equal to 2
• Informed Consent: Patients must be aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.

Exclusion Criteria:

• Major surgery or radiation therapy within 4 weeks of starting the study treatment.
• Prior hepatic artery embolization or chemoembolization.
• Prior treatment with a tyrosine kinase inhibitor or a VEGF inhibitor.
• NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment.
• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan.
• Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
• Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2.
• Prolonged QTc interval on baseline EKG.
• Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
• Known HIV or AIDS-related illness or other active infection.
• Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
• Concomitant use of ketoconazole and other agents known to induce CYP3A4.
• Concomitant use of theophylline and phenobarbital and/or other agents metabolized by the cytochrome P450 system.
• Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg po daily for thrombo prophylaxis is allowed).
• Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. Female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.