Phase I Trial of huA33 Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
Although treatment for metastatic colorectal cancer has improved significantly over the
recent years, it still remains a significant health problem representing the leading cancer
by incidence in the United States of America. In the search for new therapies, monoclonal
antibodies have been developed to specifically target human colon cancer cells. huA33 is an
antibody that reacts with the A33 antigen which is produced by colorectal cancers. Prior
studies have shown that administration of the huA33 antibody may delay the growth of tumor
cells producing the specific antigen. Oxaliplatin and 5-fluorouracil (5-FU) are cytotoxic
agents which are considered as standard treatment in metastatic colorectal cancer. Leucovorin
(folinic acid) is a vitamin which enhances the effect of 5-FU. Eligible patients with
advanced colorectal cancer will receive huA33 10 mg/m2 by intravenous (IV) infusion weekly
for twelve weeks. Starting on Study Day 15 (week 3), 5-FU, leucovorin, and oxaliplatin will
be administered every 2 weeks for 10 weeks. Patients will be evaluated weekly for toxicity.
Blood samples will be obtained every week for hematology and serum biochemistry analysis and
for determination of human anti-human antibodies (HAHA). In patients with measurable disease,
tumors will be assessed by the appropriate scan at baseline and at the end of the thirteen
week cycle. The primary objective of this study is to assess the safety of huA33 + 5-FU +
leucovorin + oxaliplatin. The secondary objective is to measure the immunogenicity of huA33
when given in combination with 5-FU plus leucovorin and oxaliplatin and to document tumor
responses.