The primary objective of the study is to determine the efficacy and safety of SU011248 as a treatment for patients with advanced unresectable neuroendocrine tumor; however, CURRENTLY ONLY RECRUITING FOR PATIENTS SPECIFICALLY WITH PANCREATIC ISLET CELL TUMORS.

Condition	Treatment or Intervention	Phase
Neuroendocrine Tumor Carcinoid Tumor	Drug: SU011248	Phase II

Further Study Details: 

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Eligible patient must be at least 18 years of age with a diagnosis of carcinoid (no longer recruiting) or pancreatic islet cell tumor. The disease must not be amenable to surgery, radiation, or combined modality therapy with curative intent
• Any side effects from prior therapy must have subsided
• Blood and urine tests must show adequate bone marrow, liver, and kidney function

Exclusion Criteria:

• The presence of any of the following will exclude a patient from study participation:
• diagnosis of small-cell carcinoma
• pheochromocytoma/paraganglioma
• Merkel cell carcinoma
• known brain or leptomeningeal disease
• cardiovascular diseases or conditions
• known HIV or AIDS-related illness
• pregancy or breastfeeding

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Alabama
      Research Center, Birmingham,  Alabama,  35233,  United States
      Research Center, Birmingham,  Alabama,  35294,  United States
      Research Center, Birmingham,  Alabama,  35233,  United States
California
      Research Center, San Francisco,  California,  94115,  United States
      Research Center, Los Angeles,  California,  90033,  United States
Illinois
      Research Center, Pinckneyville,  Illinois,  62274,  United States
Massachusetts
      Research Center, Boston,  Massachusetts,  02215,  United States
      Research Center, Boston,  Massachusetts,  02114,  United States
      Research Center, Boston,  Massachusetts,  02115,  United States
Missouri
      Research Center, St. Louis,  Missouri,  63110,  United States
Pennsylvania
      Research Center, Philadelphia,  Pennsylvania,  19111,  United States

Study ID Numbers:  RTKC-0511-015
Record last reviewed:  January 2005
Last Updated:  January 21, 2005
Record first received:  March 20, 2003
ClinicalTrials.gov Identifier:  NCT00056693
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08