Potential Imaging and 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 tumor (pNET). In addition, some traditional chemotherapies are often used to treat pNETs. 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.
The investigators routinely monitor the progress of the treatment with magnetic resonance imaging (MRI) scans to measure how pNET tumors change in size over time. MRI can also measure how water moves within tumors, which is another way to measure how tumors respond to treatment. In this study, the investigators will look at the MRI characteristics of tumors in the liver as the patient undergoes treatment, to help us identify changes on MRI that may best predict a benefit to sunitinib, everolimus or traditional chemotherapy treatment.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Pilot Study to Identify Potential Imaging and 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)|
sunitinib , everolimus or traditional chemotherapy
A total of 30 patients with well differentiated pancreatic NET who have known liver metastases and who are planned to initiate therapy with either targeted sunitinib or everolimus or traditional cytotoxic chemotherapy will be recruited for this study. We plan to recruit approximately 10 patients for each therapy. 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 sunitinib, everolimus or traditional chemotherapy according to standard of care. All patients will undergo routine follow-up MRI at approximately three months intervals. ADC of liver metastases at baseline will be compared to ADC at each follow-up MRI. In addition, a research MRI will be obtained at 2 weeks following initiation of treatment, when patients are scheduled for a clinical follow-up with their oncologists. Occasionally, patients will not be able to obtain the research MRI at exactly 2 weeks, due to scheduling constraints. A first follow-up research MRI between 1 and 3 weeks will be considered acceptable for analysis. The research MRI will be otherwise identical to the clinical MRI, which include DWI sequences. The rationale for these studies is to determine if DWI can detect changes in tumor cellularity by measuring water diffusion and serve as an early predictor for response to drug therapy.
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.|