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Title   CSOM230-2303 Safety and Efficacy of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease (LAR)
Full Title   A Multicenter, Randomized, blinded efficacy and safety study of pasireotide LAR vs. octreotide LAR in patients with metastatic carcinoid tumors whose disease-related symptoms are inadequately controlled by somatostatin analogues
Description  

Somatostatin analogues are considered standard therapy for the treatment of the disease-related symptoms of carcinoid disease. Octreotide (Sandostatin®) and lanreotide (Somatuline®) are the only two representatives of this class of compounds approved for clinical use. These drugs have been shown to be effective in reducing symptoms associated with metastatic carcinoid tumors (known as carcinoid syndrome), specifically diarrhea and flushing. These drugs are able to provide symptomatic improvement in approximately 58% to 76% of carcinoid patients. Although many patients initially respond to treatment with these drugs, adequate control cannot be achieved in approximately 50% of patients as early as 12 to 18 months after starting treatment. There is evidence that many tumor cells become resistant to these drugs over time. Pasireotide may have a beneficial effect in patients who have become resistant to these drugs. The purpose of this study is to compare the benefit of Pasireotide LAR and Octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available Somatostatin drugs. For full details: http://clinicaltrials.gov/ct2/show/study/NCT00690430?term=pasireotide&recr=Open&rank=14&show_locs=Y#locn

Eligibility Criteria   1. Patients aged 18 years or older
2. Patients with confirmedmetastatic carcinoid tumors of the digestive system with amount of disease determined by CT scan or MRI scan.
3. Patients must have inadequate control of symptoms (i.e. diarrhea and/or flushing) while receiving treatment with a maximum approved dose of a currently available somtostatin treatment for at least 3 months prior to study entry. Inadequate control is defined as:
o Diarrhea and Flushing Group (D+F): patients with 4 or more bowel movements daily and a total of 5 or more flushing episodes over a two week period (14days) while receiving treatment with the maximum approved dose of a currently available somtostatin medication for at least a 3 month period prior to study entry
o Predominantly Diarrhea Group (D): patients with with 4 or more bowel movements daily and a total of less than 5 flushing episodes over a two week period (14days) while receiving treatment with the maximum approved dose of a currently available somtostatin medication for at least a 3 month period prior to study entry
o Predominantly Flushing Group (F): patients with a 14 or more flushing episodes daily and a less than 4 bowel movements daily over a two week period (14days) while receiving treatment with the maximum approved dose of a currently available somtostatin medication for at least a 3 month period prior to study entry
4. Require occasional assistance, but is able to care for most of their personal needs or better
5. Satisfactory Liver, Kidney and blood chemistry as shown by lab tests performed before study entry
Exclusion Criteria   1. Patients who have received a somatostatin medication higher than the maximum approved dose within 3 months of Visit 1.
2. Patients who have undergone major surgery/surgical therapy for any cause within 1 month of starting treatment
3. Patients who do not have normal thyroid gland function
4. Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as indicated by HbA1C >8%
5. Patients who have been previously treated with pasireotide
6. Patient’s with poor cardiac functioning
7. Patients with additional active cancers within the last five years
8. Patients who have any current or prior medical condition that may interfere with their receiving treatment
9. Patients who are currently part of or have participated in any clinical trial testing another medication within 1 month prior to starting treatment
Principal Investigator   Steven K. Libutti, MD
Contact Name   Estella Forbes
Phone   (718) 862-8840
Contact Email   Estella Forbes
Post Date   11/18/2011
Protocol Number   BRANY 11-06-67-01/ CSOM2303
Inclusion/Notes   Interventional
Status   Active
Montefiore Clinical Trial   No
CHAM Clinical Trial   No