Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy

Running, not enrolling · Phase 1

Conditions studied: Advanced Bile Duct Carcinoma, Stage II Esophageal Cancer AJCC v7, Stage II Pancreatic Cancer AJCC v6 and v7, Stage IIA Esophageal Cancer AJCC v7, Stage IIA Pancreatic Cancer AJCC v6 and v7, Stage IIB Esophageal Cancer AJCC v7, Stage IIB Pancreatic Cancer AJCC v6 and v7, Stage III Colon Cancer AJCC v7, Stage III Esophageal Cancer AJCC v7, Stage III Gastric Cancer AJCC v7, Stage III Liver Cancer, Stage III Pancreatic Cancer AJCC v6 and v7, Stage III Rectal Cancer AJCC v7, Stage III Small Intestinal Cancer AJCC v7, Stage IIIA Colon Cancer AJCC v7, Stage IIIA Esophageal Cancer AJCC v7, Stage IIIA Gastric Cancer AJCC v7, Stage IIIA Rectal Cancer AJCC v7, Stage IIIA Small Intestinal Cancer AJCC v7, Stage IIIB Colon Cancer AJCC v7, Stage IIIB Esophageal Cancer AJCC v7, Stage IIIB Gastric Cancer AJCC v7, Stage IIIB Rectal Cancer AJCC v7, Stage IIIB Small Intestinal Cancer AJCC v7, Stage IIIC Colon Cancer AJCC v7, Stage IIIC Esophageal Cancer AJCC v7, Stage IIIC Gastric Cancer AJCC v7, Stage IIIC Rectal Cancer AJCC v7, Stage IV Colon Cancer AJCC v7, Stage IV Esophageal Cancer AJCC v7, Stage IV Gastric Cancer AJCC v7, Stage IV Liver Cancer, Stage IV Pancreatic Cancer AJCC v6 and v7, Stage IV Rectal Cancer AJCC v7, Stage IV Small Intestinal Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVA Liver Cancer, Stage IVA Rectal Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7, Stage IVB Liver Cancer, Stage IVB Rectal Cancer AJCC v7

In brief

This phase I trial studies the side effects and best dose of ropidoxuridine in treating patients with gastrointestinal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment undergoing radiation therapy. Ropidoxuridine may help radiation therapy work better by making tumor cells more sensitive to the radiation therapy.

Key facts

Study ID: NCT02381561
Run by: National Cancer Institute (NCI)
People needed: 19
Starts: 2016-02-01
Expected to finish: 2027-03-14
Last updated by the study team: 2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed advanced, incurable cancers of the esophagus, liver, stomach, small bowel, pancreas, bile duct, colon or rectum and be eligible to receive chest, abdominal and/or pelvic radiation therapy (RT) for palliation; documentation of this is required in physician note; concomitant systemic therapy is not allowed during administration of palliative RT; palliative RT can be considered for advanced primary tumors or metastatic disease as above
Patients must not have received systemic chemotherapy for at least 4 weeks, and must not have received prior radiation therapy to the tumor site being irradiated on this study
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Life expectancy of greater than 12 weeks
Leukocytes >= 3,000/mcL
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of IPdR administration
Ability to understand and the willingness to sign a written informed consent document
Human immunodeficiency virus (HIV) positive (+) patients with cluster of differentiation 4 (CD4) counts >= 250 cells/mm\^3 on anti-viral therapy
Women of child-bearing potential must have a negative pregnancy test

You may not qualify if…

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Patients who are receiving any other investigational agents
Patients with known brain metastases should be excluded from this clinical trial
History of allergic reactions attributed to compounds of similar chemical or biologic composition to IPdR
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IPdR

Where it is running

Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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