Finding studies
Finding studies
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Lead
City of Hope Medical Center
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.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
