Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients… (NCT00410956) | Clinical Trial Compass
CompletedPhase 2
Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery
United States22 participantsStarted 2007-05-09
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as floxuridine and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy directly into the arteries around the tumor together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving floxuridine and dexamethasone as a hepatic arterial infusion together with bevacizumab works in treating patients with unresectable primary liver cancer.
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 hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC)
* Peripheral, cholangiolar, or cholangiocellular types
* Mixed HCC/ICC disease allowed
* Unresectable disease
* Less than 70% liver involvement
* Radiographically bidimensionally measurable disease, defined as lesion ≥ 2 cm in the greatest diameter
* May have failed prior systemic chemotherapy or ablative therapy
* No radiographic evidence of esophageal varices
* No history of variceal hemorrhage
* No occlusion of the main portal vein or the right and left portal branches
* No clinical ascites
* Patients ineligible for first-line MSKCC protocols for HCC are eligible for this study provided there is no clinical or radiographic evidence of extrahepatic disease
* No metastatic disease, including CNS metastases
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 12 weeks
* Karnofsky performance status 60-100%
* Considered a candidate for general anesthesia and hepatic artery pump placement
* Platelet count \> 100,000/mm³
* Albumin \> 2.5 g/dL
* Bilirubin \< 1.8 mg/dL
* WBC \> 3,500/mm³
* PTT \< 1.5 times upper limit of normal
* INR \< 1.5 OR in-range INR (usually 2.0-3.0) for patients on a stable dose of therapeutic warfarin
* Urine protein \< 1+ by dipstick or urine analysis OR urine protein:creatinine ratio \< 1.0
* If proteinuria ≥ 2+ at baseline, patient must have \< 1 g protein/24-hour collection
* No concurrent disease or illness that would pre…
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.
What they're measuring
1
Median Overall Survival
Timeframe: Up to 36 months
2
Median Hepatic Progression Free Survival
Timeframe: Up to 36 months
3
Median Progression Free Survival
Timeframe: Up to 36 months
4
Antitumor Efficacy (Complete and Partial Response, Stable and Progressive Disease)