FdCyd and THU for Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasms

In brief

Background: \- FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are experimental cancer treatment drugs. FdCyd may change how genes work in cancer cells. THU helps keep FdCyd from being broken down by the body. FdCyd and THU have been given to people on other cancer treatment trials, usually by vein. Researchers want to give FdCyd and THU by mouth to see if they work against cancers that have not responded to earlier treatments. Objectives: \- To test oral FdCyd and THU on advanced solid tumors that have not responded to earlier treatments. Eligibility: \- Individuals at least 18 years of age who have advanced solid tumors that have not responded to standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and tumor samples will used to study the cancer before treatment. * FdCyd and THU will be given in 21-day cycles. THU should be taken 30 minutes before taking FdCyd. * Participants will take FdCyd and THU by mouth, once a day, for 3 days at the beginning of the first and second weeks of each cycle (days 1 3 and 8 10). The drugs will not be taken during the entire third week of each cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Treatment will continue as long as the cancer is responding to the drugs and serious side effects do not develop.

Key facts

Study ID: NCT01534598
Run by: National Cancer Institute (NCI)
People needed: 59
Starts: 2012-03-05
Expected to finish: 2025-07-21
Last updated by the study team: 2026-02-10

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known HIV infection requiring protease inhibitor therapy, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for greater than or equal to 2 months after treatment of the brain metastases. Patients should be on stable doses of anti-seizure medications. These patients may be enrolled at the discretion of the Principal Investigator.
History of allergic reactions attributed to fluoropyrimidines (e.g., capecitabine, fluorouracil, fluorodeoxyuridine) or tetrahydrouridine.
Malabsorption syndrome or other conditions that would interfere with intestinal absorption.

Where it is running

City of Hope — Duarte, California, United States
USC Norris Cancer Center — Los Angeles, California, United States
UC Davis Cancer Center — Sacramento, California, United States
National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Penn State — Hershey, Pennsylvania, United States
University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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