Active — Not RecruitingPhase 3

Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

United States298 participantsStarted 2018-10-26

Plain-language summary

This phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

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: * Documentation of Disease: * Histologic Documentation: Well- or moderately-differentiated neuroendocrine tumors of pancreatic and non-pancreatic (i.e. carcinoid) origin by local pathology * The pathology report must state ONE of the following: 1) well- or moderately-differentiated neuroendocrine tumor, 2) low- or intermediate-grade neuroendocrine tumor, or 3) carcinoid tumor or atypical carcinoid tumor; documentation of histology from a primary or metastatic site is allowed * Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma without specification of differentiation status, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible. Patients with well-differentiated grade 3 neuroendocrine tumor are eligible * Stage: Locally advanced/unresectable or metastatic disease * Tumor Site: Histological documentation of neuroendocrine tumor of pancreatic, gastrointestinal (GI), lung, thymus, other, or unknown primary site; GI, lung, thymus, other, and unknown primary NETs will enroll in the carcinoid tumor cohort of the study * Functional (i.e., associated with symptoms or clinical syndrome related to hormone secretion by tumor) or nonfunctional tumors are allowed * Radiologic Evaluation: Target lesions must have shown evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria in the 12 months prior to registration; the radiologic …

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.

1This is a Phase 3 trial testing cabozantinib in advanced pancreatic and carcinoid neuroendocrine tumors, and the main thing being measured is progression-free survival — does the data available so far suggest this drug is showing a meaningful delay in tumor growth compared to standard options for my specific type of neuroendocrine tumor?
2The trial is listed as 'active not recruiting,' which means enrollment is closed — is there any way to still access cabozantinib through a compassionate use program, expanded access, or another open trial if you think it might be right for me?
3Since cabozantinib targets tumor blood vessel growth and works differently from drugs like everolimus or sunitinib that are already approved for neuroendocrine tumors, would it make more sense to try one of those established options first before considering a trial drug like this one?
4Cabozantinib is a targeted therapy that can have side effects like high blood pressure, fatigue, and gastrointestinal issues — given my current health and any other conditions I have, how would those risks weigh against what this drug might offer for my situation?
5Because this trial covers several different types of neuroendocrine tumors — including pancreatic, lung, digestive, and thymus — is there any indication from the trial data that the results are stronger or weaker for the specific type and grade of tumor I have?

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

Progression-free Survival (PFS)

Timeframe: 36 months

Trial details

NCT IDNCT03375320

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2023-08-23

Results submitted2024-08-20

View on ClinicalTrials.gov More Functioning Pancreatic Neuroendocrine Tumor trials