Liver Metastases Clinical Trial
Official title:
A Preoperative Biological Trial of Cetuximab, Dasatinib or the Combination in Colorectal Cancer Patients With Resectable Liver Metastases
This phase 0 trial is studying whether 2 weeks of cetuximab and dasatinib will change tumor cells in patients with colorectal cancer and liver metastases that can be removed by surgery. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To evaluate the biological effects of cetuximab, dasatinib, or the combination on
epidermal growth factor receptor (EGFR)- and Src-signaling pathways in resected colorectal
cancer liver metastases.
OUTLINE: This is a multicenter study. Patients are initially enrolled in cohort A. Once
cohort A is completed, additional patients are enrolled and randomized to treatment in
either cohorts B or C. If a significant biological effect is seen in cohorts B or C,
additional patients are enrolled in cohort D.
COHORT A: Patients receive no systemic neoadjuvant therapy between enrollment and the time
of definitive surgical resection of liver metastases. Liver biopsies were performed at
surgery since this cohort received no systemic therapy.
COHORT B: Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1
and 250 mg/m^2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of
liver metastases will take place on day 15.
COHORT C: Patients receive dasatinib 100 mg orally once daily on days 1-14. Definitive
surgical resection of liver metastases will take place on day 15.
COHORT D: Patients receive 400 mg/m^2 cetuximab IV over 120 minutes on day 1 and 250 mg/m^2
cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days
1-14. Definitive surgical resection of liver metastases will take place on day 15.
Patients undergo tumor tissue (from initial liver tumor biopsies and liver resection
samples), serum, and peripheral blood mononuclear cell sample collection periodically for
biomarker analysis via immunohistochemistry (IHC).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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