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Corticosteroid

HAI + Chemotherapy +/- Bevacizumab for Liver Metastases from Colorectal Cancer

Phase 2

Waitlist Available

Led By Nancy Kemeny, M.D

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

Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study. No chemotherapy to be given after resection of liver lesions prior to treatment on this study

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

Must not have

Serious or non-healing active wound, ulcer, or bone fracture

Chronic daily treatment with aspirin (> 325 mg/d) or nonsteroidal anti-inflammatory medications known to inhibit the platelet function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding the drug bevacizumab to standard chemotherapy drugs may help improve survival in patients who have undergone liver surgery.

Who is the study for?

This trial is for adults over 18 with colorectal cancer that has spread to the liver, but not elsewhere. They must have had a liver resection and meet specific health criteria like normal blood counts and organ function tests. Pregnant women, those with recent serious injuries or surgeries, uncontrolled diseases like heart conditions or strokes, and known allergies to similar drugs are excluded.

What is being tested?

The study aims to see if adding bevacizumab (a drug that inhibits blood vessel growth in tumors) to hepatic arterial infusion of floxuridine/dexamethasone (chemotherapy delivered directly into the liver's arteries), along with systemic chemotherapy improves disease-free survival after liver surgery.

What are the potential side effects?

Bevacizumab can cause bleeding, high blood pressure, delayed wound healing, and might increase stroke risk. The chemotherapy may lead to typical side effects such as fatigue, nausea, low blood cell counts increasing infection risk, and potential liver complications.

Eligibility Criteria

Inclusion Criteria

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

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I last received chemotherapy more than 3 weeks ago and haven't had any since liver surgery.

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

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

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I am mostly able to care for myself.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious wounds, ulcers, or unhealed bone fractures.

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I take more than 325 mg of aspirin daily or use anti-inflammatory drugs that affect blood clotting.

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I have a bleeding disorder or a condition affecting blood clotting.

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My cancer has spread to my brain or central nervous system.

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I am currently pregnant or breastfeeding.

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I do not have an active infection, fluid in my abdomen, or brain issues due to liver disease.

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I have previously been treated with HAI FUDR.

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My urine protein levels are low enough to join the study.

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I do not have brain metastases or a history of major neurological conditions.

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I haven't had major surgery or significant injury in the last 28 days.

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I have not had a heart attack, uncontrolled high blood pressure, severe heart failure, serious irregular heartbeat, or major blood vessel disease in the last year.

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I have had a stroke or a transient ischemic attack.

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I have recently used medication to break up blood clots.

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I have been diagnosed with Gilbert's disease.