Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic neuroendocrine tumors (NETs). In addition, some traditional chemotherapies are often used to treat pancreatic NETs. Traditional chemotherapy is also known as "cytotoxic therapy" and works by killing cells that are actively dividing. There have been no studies to compare the different types of treatment. Since the patient is eligible for treatment with either sunitinib, everolimus or traditional chemotherapy it can help us identify factors that may help future patients benefit from these therapies.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Pilot Study to Identify Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors|
- Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]standard MRI sequences will be performed, according to guidelines from RECIST 1.1.
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]standard MRI sequences will be performed, according to guidelines from RECIST 1.1.
- best response [ Time Frame: 5 years ] [ Designated as safety issue: No ]standard MRI sequences will be performed, according to guidelines from RECIST 1.1.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
everolimus, sunitinib or traditional chemotherapy
A total of 30 patients with well differentiated pancreatic NETs who have known liver metastases and who are planned to initiate therapy with either targeted (everolimus or sunitinib) or traditional cytotoxic chemotherapy will be recruited for this study. We plan to recruit approximately 10 patients for each therapy (everolimus, sunitinib, cytotoxic chemotherapy). Evidence of metastatic disease will be determined at the discretion of the oncologist based on available imaging, surgical and pathologic evidence.
Patients will be treated with either sunitinib, everolimus, or traditional chemotherapy according to standard of care. Follow-up with imaging (either MRI or CT) will be performed approximately every 3 months. Unidimensional tumor measurement on standard CT and MRI sequences will be performed, according to guidelines from RECIST v1.1, which will be used to assess for progression of disease. Patients will be followed for up to 5 years. Upon evidence of disease progression, patients will be asked to undergo a post-treatment biopsy. If medically possible and safe, they will stay on the drug until the time of biopsy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603004
|Contact: Diane Reidy-Lagunes, MD||646-888-4185|
|Contact: Kinh Gian Do, MD, Phd||212-639-8591|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Diane Reidy-Lagunes, MD 646-888-4185|
|Contact: Kinh Gian Do, MD, PhD 212-639-8591|
|Principal Investigator: Diane Reidy-Lagunes, MD|
|Principal Investigator:||Diane Reidy-Lagunes, M.D||Memorial Sloan Kettering Cancer Center|