NCT00645710

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Liver Metastases
• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-02-11
• Primary completion: 2018-02-07
• Completion: 2018-02-07
• First posted: 2008-03-28
• Last updated: 2019-03-28
• Results posted: 2019-03-28

Locations

1 site across 1 country: United States