Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or I… (NCT02315625) | Clinical Trial Compass
TerminatedPhase 2
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: Study closed due to poor accrual.
United States16 participantsStarted 2015-04-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Progressive, histologically or cytologically diagnosed low or intermediate grade, neuroendocrine tumors confirmed by the Laboratory of Pathology, National Cancer Institute (NCI). Disease progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progression of disease or any new lesions seen on 68-Gallium DOTATATE within the 18 months prior to enrolment.
✓. Age greater than or equal 18 years, 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 will be eligible for future pediatric trials).
✓. Patients must have measurable disease according to RECIST criteria on anatomic imaging studies (computed tomography (CT) scan or magnetic resonance imaging (MRI)).
✓. Willingness to undergo tumor biopsy if the patient does not have a known familial cancer syndrome (multiple endocrine neoplasia type 1 (MEN1), Von Hippel-Lindau (VHL) and neurofibromatosis type 1 (NF1)). Archival tissue available.
✓. Eastern Cooperative Oncology Group (ECOG) performance status \<2.
✓. Patients must have normal organ and bone marrow function as defined below:
✓. Fasting serum cholesterol less than or equal 300 mg/dL OR less than or equal 7.75 mmol/L AND fasting triglycerides less than or equal 2.5x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication;
What they're measuring
1
Median Amount of Time Subject Survives Without Disease Progression After Treatment
✓. Women of childbearing potential (WOCBP) or partners of WOCBP participating in this study must agree to use highly effective contraception while on treatment and for at least 8 weeks after end of treatment, because the effects of Sunitinib and Everolimus on the developing human fetus are unknown. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Exclusion criteria
✕. 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