Ropidoxuridine for Gastrointestinal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byTimothy J Kinsella

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with advanced, incurable gastrointestinal cancers such as esophageal, liver, stomach, small bowel, pancreas, bile duct, colon or rectum cancer. They must not have had chemotherapy or radiation at the tumor site within 4 weeks and should have a life expectancy over 12 weeks. Participants need normal blood counts and organ function tests and agree to use contraception.

Inclusion Criteria

Your bilirubin levels are within the normal range for the hospital or clinic where you are being treated.

I can take care of myself but might not be able to do heavy physical work.

Your white blood cell count is at least 3,000 per microliter.

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Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IPdR

I do not have brain metastases.

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Participant Groups

The study is testing ropidoxuridine's safety and optimal dosage in combination with radiation therapy to see if it makes cancer cells more sensitive to treatment. It's a phase I trial which means it's early in the testing process focusing on finding the right dose that’s safe.

1Treatment groups

Experimental Treatment

Group I: Treatment (ropidoxuridine, IMRT)Experimental Treatment4 Interventions

Beginning 30 minutes to 2 hours before radiation therapy, patients receive ropidoxuridine PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Beginning on day 8, patients undergo IMRT 5 days a week for 3 weeks in the absence of disease progression or unacceptable toxicity.