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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01603004
First received: May 16, 2012
Last updated: April 25, 2016
Last verified: April 2016

May 16, 2012
April 25, 2016
May 2012
May 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01603004 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Potential research patients will be identified by doctors from the Gastrointestinal Oncology Service in the Department of Medicine.
Pancreatic Neuroendocrine Cancer
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 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.
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.
Intervention: Other: MRI
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
May 2017
May 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact: Diane Reidy-Lagunes, MD 646-888-4185
Contact: Kinh Gian Do, MD, Phd 212-639-8591
United States
 
NCT01603004
12-058
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Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Diane Reidy-Lagunes, M.D Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP