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Phase I Trial of Triapine and Lutetium Lu 177 Dotatate in Combination for Well-Differentiated Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
This phase I trial studies the side effects and best dose of triapine when given together with lutetium Lu 177 dotatate in treating patients with neuroendocrine tumors. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. Giving triapine and lutetium Lu 177 dotatate together may be a good way in treating patients with neuroendocrine tumors.
Primary Objective: 1) To evaluate the safety & to determine the recommended phase 2 dose (RP2D) of Lutetium Lu 177 Dotatate in combination with triapine. 2) To observe and record anti-tumor activity. Although the clinical benefit of this combination has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. 3) To determine the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 2, 4, 6, and 8 months post therapy. Secondary Objectives 1) To measure duration of response (DOR) associated with the combination. 2) To evaluate progression-free survival (PFS), 24-month PFS, and overall survival (OS). Correlative Objectives 1) Measure baseline gallium-dotatate biodistribution. 2) Evaluate oral triapine plasma pharmacokinetics and corresponding methemoglobin level by venous blood gas proportion. 3) Evaluate NETest at baseline and disease progression to correlate result with clinical outcome. 4) Describe the tumor molecular profile using whole exome sequencing (WES), as well as RNAseq by the National Clinical Laboratory Network (NCLN) Genomics Lab and correlate it with treatment outcome. 5) Collect plasma for circulating DNA (ctDNA) assessment.
Lutetium Lu 177 Dotatate (); Triapine ()