RecruitingPhase 2NCT04893785

A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)

A Phase II Single Arm Interventional Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)


Sponsor

National Cancer Institute, Naples

Enrollment

35 participants

Start Date

Jun 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of CABOTEM study is to demonstrate the safety and activity of the Cabozantinib and Temozolomide combination in Lung and GEP-NENs patients, progressing after a first line therapy, including target therapies (everolimus, sunitinib) and / or chemotherapy, in the approved setting.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (CABOTEM) is testing a combination of two drugs — cabozantinib (a targeted therapy) and temozolomide (a chemotherapy drug) — for patients with neuroendocrine tumors (NETs) of the lung or digestive system (GEP-NETs) that have progressed after other treatments like somatostatin analogues, sunitinib, everolimus, or peptide receptor radionuclide therapy (PRRT). **You may be eligible if...** - You are 18 or older with a confirmed neuroendocrine tumor of the lung or gastrointestinal/pancreatic system - Your tumor has progressed after at least one prior therapy - You have measurable disease showing progression on imaging - You have adequate organ function and are in generally good health (ECOG 0–2) - You have had appropriate washout period from prior treatments **You may NOT be eligible if...** - You have previously received temozolomide or cabozantinib - You have active brain metastases (stable, treated ones may be okay) - You have chronic hepatitis B - You have a serious heart condition or prolonged QT interval on ECG - You have had major surgery in the past 3 months - You are pregnant or breastfeeding - You have active serious bleeding, unhealed wounds, or bowel perforation history Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabozantinib and Temozolomide

Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first. Patients will be required to attend clinic on Day 1, Day 8, Day 14 and Day 22 of every 4 week cycle. Patients will return to clinic at 30 days (+/- 5 days) of their last dose of cabozantinib or temozolomide (whichever is discontinued last), for an end of treatment visit. Following their end of treatment visit patients will be followed-up 3-monthly during routine clinic appointments to collect data on further anti-cancer treatment and survival. Follow-up will continue until 6 months after the last patient stops study treatment or up to 18 months after the last patient is randomised, whichever is sooner.


Locations(1)

National Cancer Institute of Naples

Naples, Campania, Italy

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NCT04893785


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