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Completed

NCT Number: NCT01603004

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.

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Key information

Conditions

Pancreatic Neuroendocrine Cancer Adenocarcinoma Carcinoma Carcinoma, Islet Cell Carcinoma, Neuroendocrine Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neuroectodermal Tumors Neuroendocrine Tumors Pancreatic Diseases Pancreatic Neoplasms Somatostatinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Other

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.

Primary outcomes

  1. Progression free survival

    Time frame: 2 years

    standard MRI sequences will be performed, according to guidelines from RECIST 1.1.

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

    standard MRI sequences will be performed, according to guidelines from RECIST 1.1.

  2. best response

    Time frame: 5 years

    standard MRI sequences will be performed, according to guidelines from RECIST 1.1.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Pilot Study to Identify Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
May 21, 2012
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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