Phase I Trial of Radioimmunotherapy (Y-90 M5A) in Combination With FOLFIRI and Bevacizumab Chemotherapy for Metastatic Colorectal Carcinoma
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of a combination of FOLFIRI
chemotherapy, and intravenous yttrium-90 (90Y) M5A anti-CEA antibody.
SECONDARY OBJECTIVES:I. To study the progression free survival and response rate of this
combined treatment in patients with stage IV colorectal cancer.II. To evaluate the
biodistribution, clearance and metabolism of 90Y and 111In (indium-111) M5A administered
intravenously.
OUTLINE: This is a dose-escalation study of yttrium Y 90 DOTA anti-CEA monoclonal antibody
M5A. Patients receive irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV
over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90
minutes once every 2 weeks. Patients also receive yttrium Y 90 DOTA anti-CEA monoclonal
antibody M5A IV over 25 minutes once in weeks 3 and 9. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of yttrium-90 (90Y) M5A anti-CEA antibody when given in combination with FOLFIRI chemotherapy and bevacizumab
1 year post treatment
Yes
Jeffrey Wong, MD
Principal Investigator
City of Hope Medical Center
United States: Food and Drug Administration
10038
NCT01205022
April 2011
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |