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

Stopped early · Phase 2

Conditions studied: Neuroendocrine Tumors, Neuroendocrine Carcinoma, Neuroendocrine Neoplasms, Carcinoma, Neuroendocrine, Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas

In brief

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.

Key facts

Study ID: NCT02315625
Run by: National Cancer Institute (NCI)
People needed: 16
Starts: 2015-04-08
Expected to finish: 2019-05-22
Last updated by the study team: 2020-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Uncontrolled hypertension (>150/100 mmHg).
Prior external beam radiation therapy to the target lesion(s) within 1 months prior to enrollment
Prior systemic chemotherapy or therapy with one of the investigational agents within 1 month prior to enrollment.
Patients who 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.
Patients who are receiving any other investigational agents.
Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Sunitinib or Everolimus.
Patients who have any severe and/or uncontrolled medical conditions such as:
unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction less than or equal 6 months prior to start of Everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
symptomatic congestive heart failure of New York heart Association Class III or IV
active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease
known severely impaired lung function
Corrected QT interval (QTc) interval > 450 msec for males or > 470 msec for females
active, bleeding diathesis;
psychiatric illness/social situations that would preclude informed consent, limit compliance with study requirements
Pregnant or nursing patients will be excluded from the study, because the effects of Sunitinib and Everolimus on the developing human fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Sunitinib or Everolimus, breastfeeding should be discontinued if the mother is treated with Sunitinib or Everolimus.
Current treatment with therapeutic doses of Coumadin-derivative anticoagulants (low dose Coumadin up to 2 mg by mouth (PO) daily for deep vein thrombosis prophylaxis is allowed).
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study agents.
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, or the inability to take oral medication
Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HbA1c) >8% despite adequate therapy. Patients with a known history or diagnosis of diabetes mellitus who are on therapy and have had good blood sugar control may be included, even if the HbA1c is > 8% because this value can take up to 3-4 months to normalize
Patients who have received live attenuated vaccines within 1 week of start of Everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines. Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacille Calmette-Guerin (BCG), yellow fever, varicella and TY21a typhoid vaccines
Patients who are on chronic treatment with corticosteroids or other immunosuppressive agents (topical or inhaled corticosteroids are allowed)
Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
Patients who are taking medications that are strong inhibitors of cytochrome P450 AA4 (CYP3A4) or PgP and need to remain on these medications. For a current table of Substrates, Inhibitors and Inducers please access the following website:http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResourc es/DrugInteractionsLabeling/ucm093664.htm
Patients who have a history of another primary malignancy from which the patient has been disease free for < 3 years at the time of enrolment, with the exceptions of: a patient with a familial cancer syndrome-associated NETs including MEN1, VHL, NF-1, and tuberous sclerosis (TS);

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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