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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My colorectal cancer diagnosis was confirmed through lab tests.
Select...
My cancer is mainly in my liver.

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hepatic toxicity
Tumor response as measured by carcinoembryonic antigen (CEA) level, RECIST criteria, and positron emission tomography (PET) scan
Secondary outcome measures
Therapeutic efficacy based on the proportion of patients who achieve down-staging among all chemo-SIRT treated patients
Therapeutic efficacy based on time from selective internal radiation therapy (SIRT) to in-liver disease progression

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still open to new participants?

"Unfortunately, clinicaltrials.gov reports that this particular study is not presently recruiting participants. Originally posted on November 1st 2005 and last updated December 18th 2013, it has since concluded its patient search but there are 1863 other trials actively seeking individuals right now."

Answered by AI

Has irinotecan hydrochloride received official certification from the FDA?

"We at Power evaluated the safety of irinotecan hydrochloride to be a 2 due to being in Phase 2, indicating that there is some evidence for its security but none yet demonstrating effectiveness."

Answered by AI

How many participants are currently receiving treatment in this experiment?

"Unfortunately, this clinical trial has officially ended its recruitment phase. It was first listed on November 1st 2005 and the details were last updated December 18th 2013. For individuals seeking alternative studies, there are 1216 investigations that require participants with metastatic cancers and 647 trials utilizing irinotecan hydrochloride still searching for people to join their teams."

Answered by AI

To what diseases is irinotecan hydrochloride typically prescribed?

"Irinotecan hydrochloride is the primary medication employed to combat rectal carcinoma. This drug has also been seen to be successful in tackling colorectal carcinoma, ovarian cancer and sarcoma."

Answered by AI

Are there any other precedents of irinotecan hydrochloride being used in research projects?

"As of today, 647 research studies are underway pertaining to irinotecan hydrochloride. 202 of the trials have reached phase 3 and are currently recruiting patients at 27595 locations globally, with a majority based in Guangzhou, Guangdong."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver
2005. "Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00408551.
All > Colorectal Cancer Chicago > Rectal Cancer
~1 spots leftby Apr 2025
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