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Anti-metabolites

Hepatic Arterial Infusion + Chemotherapy for Colorectal Cancer Liver Metastases

Phase 1

Waitlist Available

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease confirmed at MSKCC

Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment for people who have had part of their liver removed. It's a combination of two drugs given through an IV, plus a third drug given through a pump that goes directly to the liver. The goal is to find the best dose of each drug to give, based on how well the patient tolerates the treatment.

Who is the study for?

This trial is for individuals with colorectal cancer that has spread to the liver, but not elsewhere. They must have had surgery to remove liver disease and should have acceptable blood counts and organ function. Prior chemotherapy is okay if it was over three weeks ago, but no prior radiation to the liver or certain chemotherapies like oxaliplatin.Check my eligibility

What is being tested?

The study aims to find safe doses of systemic chemotherapy (OXALIPLATIN plus 5-FLUOROURACIL and LEUCOVORIN) given by vein, and regional chemotherapy (FLOXURIDINE with DEXAMETHASONE) delivered directly to the liver in patients who've had a liver resection due to metastatic colorectal cancer.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, vomiting, low blood cell counts increasing infection risk, potential damage to healthy liver tissue which dexamethasone aims to prevent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My colorectal cancer has spread to my liver and there's no sign it has spread elsewhere.

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I last received chemotherapy more than 3 weeks ago.

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I can care for myself but may need occasional help.

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My liver cancer can potentially be fully removed by surgery, and it hasn't spread elsewhere.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Correlate thymidylate synthase, dihydropyrimidine dehydrogenase, and ERCC-1 with survival and recurrence as measured by normal and tumor liver tissue

Maximum tolerated dose

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adjuvant Hepatic Arterial Infusion & Combination ChemotherapyExperimental Treatment8 Interventions

This is a Phase I study with the primary objective of defining the maximum tolerated dose of hepatic arterial floxuridine (FUDR) and dexamethasone (Dex) given via an implanted pump in combination with intravenous oxaliplatin plus systemic fluorouracil (5FU)/leucovorin (LV) in the adjuvant setting after resection of hepatic metastases from colorectal cancer. A total of eleven dose levels will be considered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

adjuvant therapy

2004

Completed Phase 3

~3660

FOLFOX regimen

2009

Completed Phase 3

~2440

dexamethasone

1995

Completed Phase 3

~9860

conventional surgery

1994

Completed Phase 3

~13900

leucovorin calcium

1999

Completed Phase 3

~8620

oxaliplatin

2002

Completed Phase 3

~6370

floxuridine

2003

Completed Phase 3

~370

fluorouracil

1994

Completed Phase 3

~8440

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,115 Total Patients Enrolled

University of Medicine and Dentistry of New JerseyOTHER

121 Previous Clinical Trials

13,248 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,582 Total Patients Enrolled

Media Library

Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00059930 — Phase 1

Colorectal Cancer Research Study Groups: Adjuvant Hepatic Arterial Infusion & Combination Chemotherapy

Colorectal Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT00059930 — Phase 1

Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00059930 — Phase 1

Frequently Asked Questions

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

Has adjuvant therapy been validated by the FDA?

"Given the early stage of this trial, adjuvant therapy is deemed to have a level 1 safety rating by our team at Power. This phase only provides limited data regarding efficacy and safety."

Answered by AI

Are there any precedent studies that have explored the benefits of adjuvant therapy?

"Presently, 1060 clinical trials are in progress that investigate adjuvant therapy. Of these live studies, 320 have reached Phase 3 development with the majority taking place in Guangzhou, Guangdong. However, there are 40595 total medical sites operating this type of research worldwide."

Answered by AI

How many patients are partaking in this clinical trial?

"Unfortunately, this trial has already ceased recruitment. The original listing was uploaded on January 1st 2003 and the last update was made July 1st 2022. There are currently 1698 clinical studies actively seeking metastatic cancer patients and 1060 trials geared at adjuvant therapy that have yet to reach their enrollment goals."

Answered by AI

What are the typical applications of adjuvant therapy?

"Therapeutic interventions such as ophthalmia, sympathetic therapy, branch retinal vein occlusion and macular edema can abate symptoms associated with these conditions."

Answered by AI

Is recruitment still ongoing for this research project?

"Clinicaltrials.gov indicates that this particular trial, which was first posted on January 1st 2003, is not recruiting patients at present. Although it has been updated as of July 1st 2022, there are still 2758 other trials actively seeking to enrol participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer

2003. "Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00059930.

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