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Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery

NCT02315625 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-09-09

Study results available
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Summary

Background:

\- Neuroendocrine tumors (NETs) come from cells of the hormonal and nervous systems. Some people have surgery to shrink the tumor. Sometimes the tumors come back. Researchers think that treatment with drugs based on knowing the defective gene might give better results.

Objective:

\- To see if drugs selected based on the defective gene result in better tumor response. The drugs are Sunitinib and Everolimus.

Eligibility:

\- People age 18 and older with an advanced low- or intermediate-grade gastrointestinal or pancreatic neuroendocrine tumor.

Design:

* Participants will be screened with:
* Medical history
* Physical exam
* Scans
* Blood, urine, and lab tests
* The study team will see if participants should have surgery.
* If yes, participants will:
* Sign a separate consent
* Have computed tomography (CT) scan before and after surgery
* Have as much of the tumor removed as possible. A small piece will be tested for mutation type.
* If no, participants will have a small piece of tumor removed for the testing.
* If the surgery might cure them, the participant will leave the study. The other participants will be assigned to take either Sunitinib or Everolimus.
* Participants will take their drug by mouth once a day. They will keep a medicine diary. Some will keep track of their blood pressure at least weekly.
* Screening tests may be repeated at study visits. Participants also may have their heart evaluated.
* About 30 days after the last day of their study drug, participants will have a follow-up visit that repeats the screening tests.
* Participants will be contacted every 3 months after this visit.

Conditions

  • Neuroendocrine Tumors
  • Neuroendocrine Carcinoma
  • Neuroendocrine Neoplasms
  • Carcinoma, Neuroendocrine
  • Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas

Interventions

DRUG

Sunitinib

37.5 mg once daily will continue until progression or unacceptable treatment-related toxicity

DRUG

Everolimus

10 mg daily will continue until progression or unacceptable treatment-related toxicity

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Naris Nilubol, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-08
Primary Completion
2019-05-22
Completion
2019-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02315625 on ClinicalTrials.gov