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

2014-08-27 03:31:49 | BioPortfolio

Summary

RATIONALE: Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as gemcitabine and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiolabeled monoclonal antibody therapy together with gemcitabine and floxuridine after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase I trial is studying the side effects and best dose of floxuridine when given as a hepatic arterial infusion together with radiolabeled monoclonal antibody therapy and gemcitabine in treating patients with metastatic colorectal cancer and liver metastases.

Description

OBJECTIVES:

Primary

- To determine the maximum tolerated dose and dose-limiting toxicity of hepatic arterial infusion of floxuridine when administered in combination with gemcitabine hydrochloride and yttrium Y 90 anti-CEA monoclonal antibody cT84.66 in patients with metastatic colorectal carcinoma and liver metastases.

Secondary

- To study the feasibility and toxicities of this regimen.

- To evaluate the biodistribution, clearance, and metabolism of yttrium Y 90 anti-CEA monoclonal antibody cT84.66 and indium In 111 anti-CEA monoclonal antibody cT84.66.

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

- To correlate pre- and post-therapy proteomic profiles with toxicities and antitumor effects.

OUTLINE: This is a dose-escalation study of floxuridine.

Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14. Patients also receive a dosimetry dose of indium In 111 anti-CEA monoclonal antibody cT84.66 IV followed by a therapeutic dose of yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV on day 9 and gemcitabine hydrochloride IV over 30 minutes on days 9 and 11. Treatment repeats every 6-10 weeks for up to 3 courses* in the absence of disease progression or unacceptable toxicity. Patients may receive additional systemic therapy at the discretion of the treating physician.

NOTE: *Patients may receive up to 4 courses of floxuridine as a continuous hepatic arterial infusion.

Blood and urine samples are collected periodically for proteomic analysis by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry; pharmacokinetic analysis; and analysis of antibody activity and metabolism by radiometric high performance liquid chromatography.

Study Design

Primary Purpose: Treatment

Conditions

Colorectal Cancer

Intervention

floxuridine, gemcitabine hydrochloride, proteomic profiling, high performance liquid chromatography, matrix-assisted laser desorption/ionization time of flight mass spectrometry, pharmacological study, adjuvant therapy, yttrium Y 90 anti-CEA monoclonal an

Location

City of Hope Comprehensive Cancer Center
Duarte
California
United States
91010-3000

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:31:49-0400

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