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|Title||(COOPERATIVE-2 Study) Everolimus with or without Pasireotide LAR for treatment in advanced progressive Pancreatic Neuroendocrine Tumors|
|Full Title||A randomized, open-label phase II multicenter study evaluating the efficacy of oral Everolimus alone or in combination with Pasireotide LAR i.m. in advanced progressive pancreatic neuroendocrine tumors (PNET) - The COOPERATIVE - 2 study|
|Description||This study is designed to determine the treatment effect of Everolimus, a medicine known to treat cancer by stopping cancer cells from making copies and by decreasing blood supply to the cancer cells, in combination with Pasireotide LAR, a medication that works much like other somatostatin analogue medications such as Octreotide (Sandostatin®) which work to help prevent the growth of neuroendocrine tumors and control the symptoms of carcinoid syndrome; in comparison to treating patients with just Everolimus alone. Patients will be randomly assigned to receive either Everolimus alone or with Pasireotide in a 1:1 ratio (if there are two patients, each would be assigned to one or the other treatment group)|
|Eligibility Criteria||1. Advanced (not surgically treatable or spread to another place in the body), confirmed pancreatic neuroendocrine tumor (PNET).|
2. Radiological documentation (proven by CT scan or MRI) of worsening disease within the last 12 months before study treatment start.
3. Adult patients (male or female) 18 years of age or older.
4. Able to perform normal daily activities without a lot of assistance. (I.e. capable to walking a block without getting short of breath due to disease related issues)
5. No evidence of significant liver/pancreas disease (as shown by blood tests)
6. Written informed consent is to be obtained prior to any screening procedures.
|Exclusion Criteria||1. Patients currently requiring Somatostatin Analogue (SSA) treatment.|
2. Patients who received prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus), or pasireotide.
3. Patients who received any chemotherapy, radiation therapy or other biological therapy within the last 4 weeks.
4. Patients with more than 2 prior systemic treatment regimens
5. Patients who have undergone major surgery/surgical therapy for any cause within 1 month or surgical therapy of loco-regional metastases within the last 3 months prior to randomization. Patients should have recovered from the treatment and have a good clinical condition before entering this study.
6. Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent.
7. Patients who have abnormal thyroid function that is not under control using medication therapy.
8. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
• Uncontrolled diabetes as defined by HbA1c = 8% despite adequate therapy,
• High cholesterol or triglycerides even when using medication for control
• Severely impaired lung functioning.
• Patients with HIV or other immune deficiency
• Non-cancer related medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment.
• Liver disease such as Cirrhosis, decompensated liver disease, chronic active hepatitis or chronic persistent hepatitis.
• Patients who have a history of another primary cancer within the last 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of uterine cervix.
9. Patients with a history of non-cooperation to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study.
10. Pregnant or nursing women
|Principal Investigator||Steven K. Libutti, MD|
|Contact Name||Estella Forbes|
|Contact Email||Estella Forbes|
|Protocol Number||11-06-257 -01F (BRANY)|