Potential Molecular Predictors Of Response To Novel Therapies In Metastatic Pancreatic Neuroendocrine Tumors

Study Overview

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 Ȭytotoxic 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.

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Pancreatic Neuroendocrine Cancer

OTHER: MRI

12-058

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-05-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-06-24
First Submitted that Met QC Criteria 2012-05-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-06-25
First Posted (ACTUAL) 2012-05-21	Results First Posted N/A	Last Verified 2019-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
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Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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.	OTHER: MRI 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 C

Participant Group/Arm

Intervention/Treatment

: 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.

OTHER: MRI

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 C

Primary Outcome Measures	Measure Description	Time Frame
Progression free survival	standard MRI sequences will be performed, according to guidelines from RECIST 1.1.	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival	standard MRI sequences will be performed, according to guidelines from RECIST 1.1.	5 years
best response	standard MRI sequences will be performed, according to guidelines from RECIST 1.1.	5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histopathologic evidence of well differentiated pancreatic NET
Evidence of measurable disease by RECIST 1.1. Both patients with synchronous disease and those with prior resected primary cancers will be eligible.
Patient ≥18 years of age on the day of signing informed consent.
Planned initiation of active therapy with everolimus ,sunitinib or traditional cytotoxic chemotherapy.

Available archival tissue with adequate FFPE tissue for analysis verified by a pathologist (in cases of biopsies less than 2 cm and/or less than 70% tumor content 10 slides will be required for adequate DNA preparation. For larger biopsies and any resections, 5 slides are sufficient for DNA extraction).

Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy are allowed.
Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Nitya Raj, M.D, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record