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
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
V. To correlate proteomic profiles pre and post-therapy with toxicities and anti-tumor
OUTLINE: This is a phase I, dose-escalation study of floxuridine followed by a phase II
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
At 2 years
Beckman Research Institute
United States: Food and Drug Administration
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