NCT00410956

Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery

Completed Phase 2 Results posted Last updated 10 December 2024

What this trial tests

Phase 2 trial testing bevacizumab in Liver Cancer in 22 participants. Completed in 7 May 2024.

Timeline

9 May 2007

Primary endpoint
7 May 2024

7 May 2024

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	9 May 2007
Primary completion	7 May 2024
Estimated completion	7 May 2024
Sites	2 locations across United States

Drugs / interventions tested

• bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• dexamethasone (dexamethasone) — full drug profile →
• floxuridine (FLOXURIDINE) — full drug profile →
• protein expression analysis
• flow cytometry
• immunoenzyme technique
• immunohistochemistry staining method
• immunologic technique
• laboratory biomarker analysis — full drug profile →
• dynamic contrast-enhanced magnetic resonance imaging

Conditions studied

• Liver Cancer — all drugs for Liver Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

Adults 18 to 120, any sex, with Liver Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Median Overall Survival Primary · Up to 36 months

Overall median survival from time of initiation of HAI + Bev

Group	Value	95% CI
UNRESECTABLE PRIMARY HEPATIC MALIGNANCY	31.1	14 – 33.59

Median Hepatic Progression Free Survival Primary · Up to 36 months

Median Hepatic Progression Free Survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Group	Value	95% CI
UNRESECTABLE PRIMARY HEPATIC MALIGNANCY	11.28	7.93 – 15.69

Median Progression Free Survival Primary · Up to 36 months

Median Progression Free Survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Group	Value	95% CI
UNRESECTABLE PRIMARY HEPATIC MALIGNANCY	8.45	5.53 – 11.05

Antitumor Efficacy (Complete and Partial Response, Stable and Progressive Disease) Primary · Up to 36 months

Antitumor efficacy (complete and partial response, stable and progressive disease). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Group	Value	95% CI
UNRESECTABLE PRIMARY HEPATIC MALIGNANCY	7
UNRESECTABLE PRIMARY HEPATIC MALIGNANCY	15

Number of Participants Evaluated for Toxicity as Measured by NCI Common Toxicity Criteria Secondary · 2 years

Toxicity as measured by NCI Common Toxicity Criteria

Group	Value	95% CI
UNRESECTABLE PRIMARY HEPATIC MALIGNANCY	22

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 36 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

UNRESECTABLE PRIMARY HEPATIC MALIGNANCY

Serious: 12/22 (55%)

Deaths: 21/22

Serious adverse events (13 terms)

Reaction	System	UNRESECTABLE PRIMARY HEPAT…
Pain, headache, nausea	Nervous system disorders	—
Shortness of breath	Respiratory, thoracic and mediastinal disorders	—
Chest pain	General disorders	—
Mucosal tear, duodenal bulb	Eye disorders	—
Hypoglycemia	Metabolism and nutrition disorders	—
Portal hypertension, esophageal varices	Hepatobiliary disorders	—
Hyperglycemia	Metabolism and nutrition disorders	—
PV thrombosis	Hepatobiliary disorders	—
Hyponatremia	Metabolism and nutrition disorders	—
Confusion	Psychiatric disorders	—
Myocardial infarct	Cardiac disorders	—
Allergic reaction	Immune system disorders	—
Ileitis	Gastrointestinal disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	UNRESECTABLE PRIMARY HEPAT…
Liver function derangement	Hepatobiliary disorders	—
Diarrhea	Gastrointestinal disorders	—
Pain	General disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Pain, headache, nausea, Shortness of breath, Chest pain, Mucosal tear, duodenal bulb, Hypoglycemia, Portal hypertension, esophageal varices, Hyperglycemia, PV thrombosis.

Data from ClinicalTrials.gov NCT00410956 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cholangiocarcinoma: Correlation between Molecular Profiling and Imaging Phenotypes.
   Sadot E, Simpson AL, Do RK, Gonen M, et al · · 2015 · cited 43× · PMID 26207380 · DOI 10.1371/journal.pone.0132953
2. Tumor microenvironment and immunology of cholangiocarcinoma.
   Cadamuro M, Fabris L, Zhang X, Strazzabosco M. · · 2022 · cited 8× · PMID 39301518 · DOI 10.20517/2394-5079.2021.140
3. Targeted medical therapy of biliary tract cancer: recent advances and future perspectives.
   Hopfner M, Schuppan D, Scherubl H. · · 2008 · cited 6× · PMID 19084910 · DOI 10.3748/wjg.14.7021
4. Hepatic Artery Infusion Pump Therapy for Intrahepatic Cholangiocarcinoma: Indications and Outcomes.
   Ho J, Xiao S, Hernandez JM. · · 2025 · PMID 41428131 · DOI 10.1007/s12029-025-01374-x