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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Median Amount of Time Subject Survives Without Disease Progression After Treatment
. 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;
. 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