Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemothera… (NCT00492999) | Clinical Trial Compass
Active — 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
United States64 participantsStarted 2007-05
Plain-language summary
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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.