Overview

KRAS Wild-type Metastatic Colorectal Cancer Trial

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
OBJECTIVES: Primary Objectives 1.To evaluate the safety and feasibility of the sequential use of a DNA methyltransferase (DNMT) inhibitor (decitabine) with a targeted biological agent against EGFR (panitumumab) for KRAS wild type tumors in the second or third line treatment of advanced metastatic colorectal cancer. Secondary Objectives 1. To examine re-expression or a reduction in promoter methylation in genes involved in tumor suppressor pathways known to be important in colorectal cancer (CRC) or involved in EGFR signaling pathway. 2. Evaluate overall response (OR = CR +PR) according to RECIST criteria at 2, 4, and 6 cycles. Progression free survival, measured as the first evidence of tumor growth from the start of treatment will also be assessed. 3. Measure CEA levels at the beginning of each cycle to examine if they correlate with treatment response or disease progression.
Phase:
Phase 1
Details
Lead Sponsor:
University of Utah
Collaborators:
Amgen
Eisai Inc.
Treatments:
Antibodies, Monoclonal
Azacitidine
Decitabine
Panitumumab