Trial Type: Colorectal Cancer
Trial Status: Past Trial

Edward Lin, MD
Fred Hutchinson Cancer Research Center, University of Washington

The usual treatment for metastatic colorectal cancer includes chemotherapy, radiation and surgical resection. Unfortunately, the average survival rate has been only 20-24 months.

In a Phase I pilot study, Dr. Lin’s team was able to achieve a survival rate of approximately 94+ months using a new approach called ADAPT – Activate tumor from Dormancy And Potentiate its Targeting. Dormant cancer stem cells resist chemotherapy and survive to grow new tumors. The ADAPT method “wakes up” the stem cells so they become vulnerable to chemotherapy. In the pilot study, the cells were exposed to both a chemotherapeutic assault and a common anti-inflammatory drug which damaged their ability to act as stem cells. The improved survival rate indicated there may be an advantage for a non-surgical approach.

This exciting Phase II study will compare this new Two-Step ADAPT regimen to the standard of care for metastatic colorectal patients. In addition to hoping to achieve long-term, cancer-free results, Dr. Lin is looking for genetic tumor biomarkers that may predict which patients will best respond to the ADAPT therapies. [Awarded 2011]


Clinical Summary
A multi-center randomized phase II trial of ADAPT therapy vs standard of care for patients with metastatic colorectal cancer. Colorectal cancer is a common and deadly cancer. The chief cause of treatment failure is due to the presence of cancer stem cells. The cancer stem cells go into hibernation during chemotherapy and ‘wake up’ when chemotherapy is withdrawn or the tumor cells become tolerant to drugs. To target the cancer stem cells is by activating these cells from dormancy and priming them for subsequent targeting. In this phase II clinical trial, Dr. Lin is studying the effects of his two step ADAPT therapy on metastatic colorectal cancer patients. Dr. Lin’s unique therapy combines two drugs: Xeloda (chemotherapy drug) with Celebrex a nonsteroidal anti-inflammatory drug that is often used for treating arthritis. It is the unique combination of these two drugs that has improved the outcome of colorectal cancer by targeting the cancer stem cells. “We’re using the Gateway funding to prospectively prove that you can induce complete remission in patients with colon cancer,” said Dr. Lin. Further, this phase II colon cancer study will determine if specific biologic markers can help predict which patients are likely to respond to the ADAPT therapy.

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