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NCT00492999Active, not recruitingPhase 2

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 · Last updated 3 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
64 (estimated)
First submitted
25 Jun 2007
Start date
May 2007
Primary completion date
May 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT00492999

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 64
  • From May 2007 to the primary completion date, May 2027
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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 agents

Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Cancer Center
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center @ Suffolk
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Memorial Sloan Kettering at Mercy Medical Center
Coordinator of this site? Confirm its status
Rockville CentreUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital
Coordinator of this site? Confirm its status
Sleepy HollowUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.