Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/6/2018
Start Date:May 2012
End Date:May 2019
Contact:Nitya Raj, MD
Phone:646-888-4849

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A Pilot Study to Identify 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.


Inclusion Criteria:

- 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.

Patients can be included in this study, regardless of prior therapy, but cannot undergo
concurrent therapy, such as hepatic artery embolization

- 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).

Exclusion Criteria:

- 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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Nitya Raj, MD
Phone: 646-888-4849
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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