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COMPLETED
NCT00645710
PHASE1/PHASE2

Hepatic Arterial Infusion of Floxuridine, Gemcitabine Hydrochloride, and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer Previously Treated With Surgery

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

RATIONALE: Drugs used in chemotherapy, such as floxuridine and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry cancer-killing substances directly into the liver. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving hepatic arterial infusion of floxuridine together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I/II trial is studying the side effects and best dose of floxuridine when given as a hepatic arterial infusion together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy and to see how well it works in treating liver metastases in patients with metastatic colorectal cancer.

Official title: A Phase I/II Trial of Radioimmunotherapy (Y-90 cT84.66), Gemcitabine and Hepatic Arterial Infusion of Fudr for Metastatic Colorectal Carcinoma to the Liver

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2005-06-13

Completion Date

2018-02-07

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

gemcitabine hydrochloride

Given IV

DRUG

floxuridine

Given via hepatic arterial infusion

GENETIC

proteomic profiling

Correlative studies

OTHER

matrix-assisted laser desorption/ionization time of flight mass spectrometry

Correlative studies

OTHER

liquid chromatography

Correlative studies

RADIATION

yttrium Y 90 anti-CEA monoclonal antibody cT84.66

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

mass spectrometry

Correlative studies

OTHER

pharmacological study

Correlative studies

Locations (1)

City of Hope

Duarte, California, United States