drugset / Trial / NCT05247905

Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors, the ComPareNET Trial

NCT05247905 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial compares the effect of combination therapy with capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or that cannot be removed by surgery (unresectable). Temozolomide and capecitabine are considered chemotherapy drugs. Temozolomide is in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid and may kill cancer cells. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate, builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Treatment with lutetium Lu 177 dotatate may be more effective than combination therapy with temozolomide and capecitabine in shrinking or stabilizing cancer in patients with advanced or unresectable neuroendocrine tumors.

Timeline

Start
2023-02-16
Primary completion
2028-03-31
Completion
2033-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-DOTATATE Peptide — Intravenous
Subject Capecitabine Small molecule — Oral
Subject Temozolomide Small molecule — Oral