drugset / Trial / NCT05247905

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

NCT05247905

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial compares 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 are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic 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