Title: Phase I and Pharmacology Study of Oral 5-Iodo-2-Pyrimidinone-2′- Deoxyribose (IPdR) as a Prodrug for IUdR-Mediated Tumor Radiosensitization in Gastrointestinal Cancers1

Principal Investigator: Timothy Kinsella, MD, Rhode Island Hospital

Description: For this open label, dose-escalation phase 1 study (ClinicalTrials.gov Identifier: NCT02158234), researchers are assessing the toxicity profile and efficacy of ropidoxuridine in patients with metastatic gastrointestinal cancer unlikely to respond to radiation. Ropidoxuridine may sensitize cancer cells to radiation therapy.

Patients with stage II to IVB gastrointestinal tumors (bile duct carcinoma, esophageal, pancreatic, colon, gastric, liver, rectal, or small intestinal cancer) will receive oral ropidoxuridine daily for 28 days. On day 8, patients will receive intensity-modulated radiation therapy 5 days a week for 3 weeks. Ropidoxuridine will be administered 30 minutes to 2 hours prior to radiation therapy.

The primary objective is to determine a maximum tolerated dose of ropidoxuridine. Secondary objectives include anti-tumor activity.

The estimated study enrollment is 30 patients.

For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02381561.

Status: Open and recruiting patients as of November 20, 2017.

This study is sponsored by the National Cancer Institute (NCI).

Reference

  1. ClinicalTrials.gov. Ropidoxuridine in treating patients with advanced gastrointestinal cancer undergoing radiation therapy. NCT02381561. https://clinicaltrials.gov/ct2/show/NCT02381561. Accessed November 21, 2017.