TAS-102 in Extrapulmonary Neuroendocrine Carcinoma (NCT04042714) | Clinical Trial Compass
TerminatedPhase 2
TAS-102 in Extrapulmonary Neuroendocrine Carcinoma
Stopped: Study halted due to low enrollment
United States14 participantsStarted 2019-08-15
Plain-language summary
The purpose of this study is to test the safety and efficacy of drug, TAS-102 (trifluridine/tipiracil), in patients with extrapulmonary (outside the lung) high-grade neuroendocrine cancer. TAS-102 demonstrated improved survival and tolerability in patients with colorectal cancer and is currently approved by the FDA and marketed under the brand name Lonsurf for the treatment of patients with metastatic colorectal cancer (mCRC). Recently, a study evaluating TAS-102 showed a case of complete remission of high-grade NEC. Given the safety profile of TAS-102 and the remarkable single agent activity in a disease with otherwise dismal outcomes, we hope that TAS-102 may show tolerability and efficacy in neuro-endocrine cancer and propose further exploration in patients with extrapulmonary (outside the lung) high-grade neuroendocrine cancer.
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:
* Pathologic confirmation of high grade NEC using WHO criteria as determined by Ki67\>20%, poorly differentiated (G3) characteristics, or \>20 mitotic figures/10 high-power fields.
* Unknown primary may be included. Suspected extrapulmonary patients with known lung primary will be excluded.
* Prior treatment with a platinum containing regimen
* RECIST 1.1 measurable disease
* Evidence of stage IV, metastatic disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
* Serum albumin ≥2.5 gm/dL.
* Expected survival ≥3 months.
* Adequate hematologic function as defined by: a) Absolute neutrophil count (ANC) \>1500/mm3; b) Platelets ≥75,000/mm3; c) Hemoglobin \>8 g/dL (in the absence of red blood transfusion).
* Adequate liver function, as defined by: a) Serum total bilirubin ≤2.5 x ULN mg/dL. b) ALT (SGPT) and AST (SGOT) ≤5 x upper limit of normal (ULN).
* Adequate renal function, as defined by serum creatinine ≤2.0 x ULN, or creatinine clearance ≥30 mL/min
* Females of child bearing potential must agree to use contraception to avoid pregnancy throughout the study.
Exclusion Criteria:
* Women who are pregnant or breastfeeding.
* Evidence of low-grade or well-differentiated features as determined by the investigator.
* Functional neuroendocrine tumors are excluded.
* Known pulmonary primary or small cell lung cancer will be excluded.
* Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricul…
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.