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Treatment Study for Patients with Advanced Neuroendocrine Tumors

Clinical Trial Title: 
A phase II trial of mutation-targeted therapy with sunitinib or everolimus in patients with advanced low- or intermediate-grade neuroendocrine tumors of the gastrointestinal tract and pancreas with or without cytoreductive surgery.
Clinical Trial Protocol ID: 
16090107
Clinical Trial Investigator Name: 
Xavier M. Keutgen, MD
Clinical Trial Protocol Description: 

Study for sunitinib or everolimus with or without cytoreductive surgery for subjects with gastrointestinal cancers and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have progressive, histologically or cytologically diagnosed low or intermediate grade, neuroendocrine tumors confirmed by the Laboratory of Pathology, NCI. Disease progression is defined according to RECIST criteria for progression of disease or any new lesions seen on 68-Gallium DOTATATE within 18 months prior to enrolment.
  • Are 18 years of age or older. Because the incidence and prevalence of metastatic pancreatic and gastrointestinal neuroendocrine tumors in the pediatric patient population is exceedingly rare, children are excluded from this study, but may be eligible for future pediatric trials.
  • Have measurable disease according to RECIST criteria on anatomic imaging studies (CT scan or MRI).
  • Are willing to undergo tumor biopsy if there is not a known familial cancer syndrome (MEN1, VHL and NF1). Archival tissue, if available, can be used if fresh tumor biopsy is not an option.

You will be excluded from the study if any of the following criteria apply to you:

  • Have uncontrolled hypertension (greater than150/100 mmHg).
  • Have had prior external beam radiation therapy to the target lesion(s) within 1 months prior to enrollment.
  • Have had prior systemic chemotherapy or therapy with one of the investigational agents within 1 month prior to enrollment.
  • Have had therapy with one of the investigational agents more than 1 month prior to enrollment in whom tumor genotyping show assignment to the same investigational agent.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Gastrointestinal Cancers
Contact Phone: 
(312) 563-3347
Contact Name: 
Deborah Pach, RN