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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

Liver Metastases Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) and associated toxicities of concurrent hepatic arterial infusion (HAI) fluorodeoxypyrimidine (FUdR)/Decadron and intravenous gemcitabine combined with intravenous yttrium-90 (^90Y) chimeric T84.66 (cT84.66) in colorectal cancer patients after hepatic resection or maximum surgical debulking (to < 3 cm) of liver metastases.

II. To study the feasibility and toxicities of such adjuvant therapy following resection and/or ablation of liver metastases.

III. To evaluate the biodistribution, clearance and metabolism of ^90Y and ^111In (indium-iii) chimeric T84.66 administered intravenously.

IV. To estimate radiation doses to whole body, normal organs, and tumor through serial nuclear imaging.

V. To correlate proteomic profiles pre and post-therapy with toxicities and anti-tumor effects.

OUTLINE: This is a phase I, dose-escalation study of floxuridine followed by a phase II study.

Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician.

After completion of study treatment, patients are followed up at 3 and 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00645710
Study type Interventional
Source City of Hope Medical Center
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 11, 2005
Completion date February 7, 2018
View Details
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