Liver-Directed chemo may shrink tumors enough for surgery in colorectal cancer
NCT ID NCT00492999
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests whether delivering chemotherapy directly into the liver (hepatic arterial infusion) along with standard IV chemo can shrink inoperable liver tumors from colorectal cancer enough to allow surgical removal. The study involves 64 participants whose cancer has spread only to the liver. The goal is to see how many patients become eligible for liver surgery, which could improve their chances of long-term survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- floxuridine and dexamethasone given directly into the liver artery, plus standard IV chemotherapy
- What this could lead to
- If successful, this approach could make more patients eligible for liver surgery, potentially improving long-term survival for those with colorectal cancer that has spread only to the liver.
- What could go wrong
- This is a mid-stage trial with only 64 participants, so results may not apply broadly. The treatment involves complex procedures and strong chemotherapy, which carry risks like infection, liver damage, and side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2007
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
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Memorial Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York, United States
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Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
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