Clinical trial · Interventional
Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
A Phase II Study of the Rate of Conversion to Complete Resection in Patients With Initially Inoperable Hepatic-Only Metastases From Colorectal Cancer After Treatment With Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving floxuridine and dexamethasone directly into the arteries around the tumor together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine and dexamethasone works when given together with combination chemotherapy in treating patients with colorectal cancer that has spread to the liver.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| floxuridine | Drug | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Patients receive hepatic arterial infusion (HAI) therapy comprising floxuridine and dexamethasone continuously on days 1-14. Patients also receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 30 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: dexamethasone
- Drug: floxuridine
- Drug: irinotecan hydrochloride
- Drug: oxaliplatin
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Patients receive HAI therapy as in group 1. Patients also receive irinotecan hydrochloride IV over 30 minutes and leucovorin calcium IV over 30 minutes on days 1 and 15 and fluorouracil IV continuously over 48 hours on days 1, 2, 15, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: dexamethasone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed colorectal adenocarcinoma metastatic to the liver
* Previously treated or untreated disease
* No clinical or radiographic evidence of extrahepatic disease
* Primary tumor may be present at study registration provided it is not obstructing the intestinal lumen or is significantly bleeding
* If present, the primary tumor will be resected at the time of pump placement
* Must have inoperable liver metastases confirmed by 2-3 hepatobiliary surgeons and the assigned radiologist
* Liver metastases \< 70% of the liver parenchyma
* Inoperable liver metastases is defined by one of the following:
* More than 6 metastases in a single lobe with one lesion ≥ 5 cm
* At least 6 metastases distributed diffusely in both lobes of the liver
* When a margin-negative resection would require resection of all three hepatic veins, both portal veins, or the retrohepatic vena cava
* Requires a resection that leaves \< 2 hepatic segments (not including the caudate lobe) behind with adequate arterial or portal inflow, venous outflow, and biliary drainage
* No ascites or hepatic encephalopathy
* No history of primary CNS tumors
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* WBC ≥ 3,000/mm\^3
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* INR \< 1.5
* Hemoglobin ≥ 9 g/dL
* Creatinine ≤ 1.5 mg/dL
* Total bilirubin ≤ 1.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Physically able to tolerate major partial hepatectomy
* No active infection
* No concurrent active malignancies, except potentially resectable primary colorectal tumor
* No bleeding diathesis or coagulopathy
* No history of serious systemic disease, including any of the following:
* Myocardial infarction within the past 6 months
* Uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg on medication)
* Unstable angina
* New York Heart Association class II-IV congestive heart failure
* Unstable symptomatic arrhythmia requiring medication
* Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
* Peripheral vascular disease ≥ grade 2
* No serious or nonhealing active wound, ulcer, or bone fracture
* No history of seizures not well controlled with standard medical therapy
* No stroke or transient ischemic attack within the past 6 months
* No concurrent obstruction of the gastrointestinal or genitourinary tract
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior radiotherapy to the pelvis
* Prior chemotherapy allowed
* No prior radiotherapy, hepatic thermal ablation, or resection (other than biopsy) to the liver
* No prior floxuridine
* No prior hepatic arterial infusion
* No concurrent chronic aspirin (\> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function
* No other concurrent investigational agentsReferences
Publications (2)
- DERIVEDCorrea-Gallego C, Gavane S, Grewal R, Cercek A, Klimstra DS, Gewirtz AN, Kingham TP, Fong Y, DeMatteo RP, Allen PJ, Jarnagin WR, Kemeny N, D'Angelica MI. Prospective evaluation of 18F-fluorodeoxyglucose positron emission tomography in patients receiving hepatic arterial and systemic chemotherapy for unresectable colorectal liver metastases. HPB (Oxford). 2015 Jul;17(7):644-50. doi: 10.1111/hpb.12421. Epub 2015 May 23. PMID 26010778
- DERIVEDD'Angelica MI, Correa-Gallego C, Paty PB, Cercek A, Gewirtz AN, Chou JF, Capanu M, Kingham TP, Fong Y, DeMatteo RP, Allen PJ, Jarnagin WR, Kemeny N. Phase II trial of hepatic artery infusional and systemic chemotherapy for patients with unresectable hepatic metastases from colorectal cancer: conversion to resection and long-term outcomes. Ann Surg. 2015 Feb;261(2):353-60. doi: 10.1097/SLA.0000000000000614. PMID 24646562