Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors (NCT03950609) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors
United States36 participantsStarted 2019-07-30
Plain-language summary
This phase II trial studies how well lenvatinib and everolimus work in treating patients with carcinoid tumors that have spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Lenvatinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell 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:
* Histologically or cytologically confirmed unresectable well differentiated (irrespective of grade) carcinoid tumors. Patients with multiple neuroendocrine tumors associated with MEN1 syndrome will be eligible
* Patients must have radiographically measurable disease. Lesions that have had locoregional therapies such as radiofrequency (RF) ablation, radiation or transarterial therapies must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
* Patients with other gastrointestinal neuroendocrine tumors must have had progressive disease over the last 12 months irrespective of number of prior therapies. Patients with both functional (who may continue somatostatin analogues as required for control of related symptoms) and non-functional tumors are eligible.
* Written informed consent must be obtained prior to any screening procedures.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
* A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies and major surgery) and enrollment, to allow the effects of prior therapy to have abated:
* Cytotoxic or targeted chemotherapy: \>= the duration of the cycle of the most recent treatment regimen (a minimum of 3 weeks for all regimens, except 6 weeks for nitrosoureas and mitomycin-C)
* Biologic therapy (e.g., antibodies): \>= 4 weeks.
* Absolute neutrophil count…
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
Radiographic response rate
Timeframe: Up to 30 days after completion of study treatment
2
Objective response rate
Timeframe: Up to 30 days after completion of study treatment