KRAS Wild-type Metastatic Colorectal Cancer Trial

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.

Timeline

Start

2009-12

Primary completion

2013-01

Completion

2013-01

Publications

• Garrido-Laguna I, McGregor KA, Wade M, Weis J, Gilcrease W, Burr L, Soldi R, Jakubowski L, Davidson C, Morrell G, Olpin JD, Boucher K, Jones D, Sharma S. A phase I/II study of decitabine in combination with panitumumab in patients with wild-type (wt) KRAS metastatic colorectal cancer. Invest New Drugs. 2013 Oct;31(5):1257-64. doi: 10.1007/s10637-013-9947-6. Epub 2013 Mar 17.

Drugs

Indications