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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00410956
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • dexamethasone — DRUG
  • floxuridine — DRUG
  • protein expression analysis — GENETIC
  • flow cytometry — OTHER
  • immunoenzyme technique — OTHER
  • immunohistochemistry staining method — OTHER
  • immunologic technique — OTHER
  • laboratory biomarker analysis — OTHER
  • dynamic contrast-enhanced magnetic resonance imaging — PROCEDURE

Study Details

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.

Key Dates

First listed
Dec 13, 2006
Start date
May 9, 2007
Status verified
May 2024
Primary completion
May 7, 2024
Completion
May 7, 2024

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: UNRESECTABLE PRIMARY HEPATIC MALIGNANCY
    All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump.

Primary Outcome Measure

Median Overall Survival [ Time Frame: Up to 36 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
New York Weill Cornell Cancer Center at Cornell UniversityNew YorkNew York10021-

Find similar trials in New York, NY

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Memorial Sloan-Kettering Cancer Center· New York, NYNew York Weill Cornell Cancer Center at Cornell University· New York, NY

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