Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00492999
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • dexamethasone — DRUG
    Given by hepatic arterial infusion
  • floxuridine — DRUG
    Given by hepatic arterial infusion
  • fluorouracil — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • oxaliplatin — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
May 31, 2007
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Patients receive hepatic arterial infusion (HAI) therapy comprising floxuridine and dexamethasone continuously on days 1-14. Patients also receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 30 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group 2
    Patients receive HAI therapy as in group 1. Patients also receive irinotecan hydrochloride IV over 30 minutes and leucovorin calcium IV over 30 minutes on days 1 and 15 and fluorouracil IV continuously over 48 hours on days 1, 2, 15, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Resectability rate [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterBasking RidgeNew Jersey--
Memorial Sloan Kettering Cancer Center @ SuffolkCommackNew York11725-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering at Mercy Medical CenterRockville CentreNew York--
Memorial Sloan Kettering Cancer Center@Phelps Memorial HospitalSleepy HollowNew York--

Find similar trials in Basking Ridge, NJ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Memorial Sloan Kettering Cancer Center· Basking Ridge, NJMemorial Sloan Kettering Cancer Center @ Suffolk· Commack, NYMemorial Sloan Kettering Cancer Center· New York, NYMemorial Sloan Kettering at Mercy Medical Center· Rockville Centre, NYMemorial Sloan Kettering Cancer Center@Phelps Memorial Hospital· Sleepy Hollow, NY

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