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Corticosteroid

HAIP Chemotherapy for Metastatic Colorectal Cancer

Phase 2
Recruiting
Led By Jonathan M Hernandez, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma.
Patients must have progressed on, been intolerant of or have residual disease after oxaliplatin- or irinotecan-containing, fluorouracil-based, chemotherapeutic regimen.
Must not have
Patients with liver metastases amenable to resection to No Evidence of Disease (NED) in one stage.
MSI-high patients who need to be treated with check-point inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at progression
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people with colorectal cancer that has spread to their liver. It is testing if a pump that gives chemotherapy drugs directly to the liver for 2 weeks at a time is effective.

Who is the study for?
Adults over 18 with colorectal cancer that has spread to the liver, who have tried or can't tolerate certain chemotherapy regimens. They must be in good physical condition (ECOG ≤1), have proper organ and marrow function, and agree to use contraception. Excluded are those with high-risk genetic features needing other treatments, serious illnesses, active infections like Hepatitis B/C, pregnant/nursing women, other cancers within five years (except some skin/thyroid cancers), or those eligible for complete surgical removal of liver metastases.
What is being tested?
The trial is testing a hepatic artery infusion pump delivering Floxuridine and Dexamethasone directly into the liver combined with systemic chemotherapy drugs like cetuximab and irinotecan. Participants will undergo cycles of treatment including regular exams, blood tests every two weeks for chemo via catheter/port, scans every three months, and possible tissue sampling.
What are the potential side effects?
Potential side effects include reactions at the catheter site on the abdomen where the pump is placed under the skin; general side effects from chemotherapy such as fatigue; nausea; low blood counts leading to increased infection risk; potential harm to unborn children which necessitates contraception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is colorectal adenocarcinoma confirmed by lab tests.
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My cancer did not respond or worsened after treatment with specific chemotherapy drugs.
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I am 18 years old or older.
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I am fully active or have some restrictions but can still care for myself.
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I have cancer that has spread to my liver and it can be measured.
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My kidney function tests are within normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver cancer can be surgically removed until there's no visible disease.
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I have MSI-high cancer and need treatment with checkpoint inhibitors.
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I do not have any serious illnesses that my doctor thinks could make this study unsafe for me.
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I am not pregnant or breastfeeding if I want to participate in this study.
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I do not have an active Hepatitis B or C infection.
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I have had radiation therapy to my liver.
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My cancer has spread beyond my colon/rectum and liver, making liver-focused treatments unlikely to help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at progression
This trial's timeline: 3 weeks for screening, Varies for treatment, and at progression for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response rate (RR)
Secondary study objectives
Extra-hepatic progression-free survival
Hepatic progression-free survival
Overall survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/ Arm 1Experimental Treatment9 Interventions
HAIP chemotherapy + Systemic chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cetuximab
2000
Completed Phase 3
~7290
Irinotecan
2017
Completed Phase 3
~2590
5FU
2016
Completed Phase 3
~250
Panitumumab
2017
Completed Phase 3
~7150
Oxaliplatin
2011
Completed Phase 4
~2890

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,020 Total Patients Enrolled
Jonathan M Hernandez, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
1,911 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03366155 — Phase 2
Colorectal Cancer Research Study Groups: 1/ Arm 1
~19 spots leftby Dec 2029
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