Study evaluating SOM230 in patients with metastatic carcinoid tumors

Condition	Treatment or Intervention	Phase
Carcinoid Tumors	Drug: Sandostatin LAR  Drug: SOM230	Phase II

Further Study Details: 

Expected Total Enrollment:  36

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• patients with biopsy-proven metastatic carcinoid tumors
• patients with at least one measurable lesion (excluding bone)
• Patients must be considered inadequately controlled while on Sandostatin LAR therapy based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as experiencing a minimum average of at least four bowel movements per day or a minimum average of at least two episodes of flushing per day

Exclusion Criteria:

• Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
• Patients who have undergone major recent surgery / surgical therapy for any cause within 1 month
• Patients on any chemotherapy or interferon therapy within the last 2 months
• Patients with uncontrolled diabetes mellitus
• Patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy
• Patients who have congestive heart failure unstable angina, cardiac arrhythmia or a history of acute myocardial infarction within the three months preceding enrollment
• Patients with chronic liver disease
• Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control.
• History of immunocompromise, including a positive HIV test result
• Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving SOM230
• Patients who have given a blood donation (of 400 mL or more) within 2 months before receiving SOM230
• Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
• Patients with additional active malignant disease within the last five years

California
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States
Iowa
      Univ. Of Iowa Holden Cancer Center, Iowa City,  Iowa,  52242,  United States
Louisiana
      Louisiana State University Medical Center, New Orleans,  Louisiana,  70112,  United States
France
      Hospital Beaujon Service de Gastroenterologie, Clichy,  France
Germany
      Universitatsklinikum Charite- Virchow-Klinikum, Berlin,  Germany
Netherlands
      Academic Ziekenhis Inwendige Geneeskunde, Rotterdam,  Netherlands
Sweden
      University Hospital Department of Internal Medicine, Uppsala,  Sweden

Study ID Numbers:  CSOM230B2202
Record last reviewed:  February 2005
Last Updated:  February 9, 2005
Record first received:  July 30, 2004
ClinicalTrials.gov Identifier:  NCT00088595
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08