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Anti-tumor antibiotic

Chemotherapy + Internal Radiation for Colorectal Cancer

Phase 2
Waitlist Available
Research Sponsored by Goshen Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed colorectal cancer meeting specific criteria as outlined
Liver-only or liver-predominant disease with certain characteristics
Must not have
Hepatic metastases from a second malignancy
Active CNS metastasis or diffuse peritoneal metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is studying chemotherapy and internal radiation to see how well they work in treating patients with colorectal cancer.

Who is the study for?
This trial is for adults with colorectal cancer that has spread to the liver. They must be using effective contraception if fertile, have a certain level of hemoglobin in their blood, and not have had previous radiation therapy to the liver. People with active brain metastasis or significant disease outside the liver are excluded.
What is being tested?
The study tests how well chemotherapy drugs (floxuridine, irinotecan hydrochloride, oxaliplatin, leucovorin calcium, fluorouracil) work alongside internal radiation in killing tumor cells in patients whose colorectal cancer has spread to the liver.
What are the potential side effects?
Chemotherapy may cause nausea, vomiting, hair loss, fatigue and increased risk of infection. Internal radiation could lead to localized pain or discomfort at the treatment site and potential damage to surrounding healthy tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My colorectal cancer diagnosis was confirmed through lab tests.
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My cancer is mainly in my liver.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have liver metastases from another cancer.
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My cancer has spread to my brain or throughout my abdomen.
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My cancer is mainly outside the liver.
Select...
I have had radiation therapy targeted at my liver before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Group I: FUDRExperimental Treatment1 Intervention
Patients receive floxuridine IV continuously on days 1-14.
Group II: FOLFOX6Experimental Treatment3 Interventions
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continously over 46 hours beginning on day 1.
Group III: FOLFIRIExperimental Treatment3 Interventions
Patients receive irinotecan hydrochloride IV over 1 hour and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Floxuridine
FDA approved
Irinotecan
FDA approved
Oxaliplatin
FDA approved
Leucovorin
FDA approved
Fluorouracil
FDA approved

Find a Location

Who is running the clinical trial?

Goshen Health SystemLead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
Kenneth L. Pennington, MDStudy ChairGoshen Health System
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Floxuridine (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00408551 — Phase 2
Colorectal Cancer Research Study Groups: FUDR, FOLFOX6, FOLFIRI
Colorectal Cancer Clinical Trial 2023: Floxuridine Highlights & Side Effects. Trial Name: NCT00408551 — Phase 2
Floxuridine (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00408551 — Phase 2
~1 spots leftby Sep 2025
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