At the ECCO/ESMO  meeting in Berlin the data on a large phase III clinical trial from the United Kingdom (COIN) was presented. It was a trial comparing FOLFOX or XELOX in combination with Erbitux.

It is important to know that in the UK Avastin is not approved, and Erbitux was only recently approved in patients with organ limited disease based on the chance of curative resections in patients initially deemed not to be resectable. However it is difficult to judge what the COIN results mean. The response rates in the patients with wild-type KRAS was significantly increased to 64%, so far so good. The problem is that the time to tumor progression and overall survival was not improved in patients with wild-type KRAS and Erbitux therapies. Read the rest of this entry »

Oxford University

Nancy Roach is the Founder of C3 and Chair of the Board of Directors.

On September 5 -6, I put on my sensible black shoes to attend the second Sensible Guidelines for the Conduct of Clinical Trials meeting at Oxford University in England.  This invitation-only meeting convened research leaders to discuss how to improve large randomized clinical trials.

Why “Sensible Guidelines”?

People are the ‘experimental subjects’ of clinical research. Since World War II, laws and regulations have been passed to make sure that research participants are protected during the conduct of clinical trials. Over time – and especially in the last decade – many of the well-meaning laws and regulations have had an unintended consequence:  bureaucracy that does not always protect or help patients, but does eat up resources. Patients in trials often see only the tip of the bureaucratic iceberg, while research staff, academic institutions, government agencies and drug companies struggle with the rest of it.

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An oral drug that blocks activity of enzymes that change proteins in cells that leads to cancer is being tested at the National Institutes of Health.

R935788 or Fostamatinib, a protein kinase inhibitor, is in a Phase II clinical trial for patients with several types of advanced cancer, including colorectal cancer.  Patients whose cancer has gotten worse on previous treatment are eligible to participate.  The trial is being conducted at the NIH Clinical Center in Bethesda, Maryland. Read the rest of this entry »

Scientists at the University of Pittsburgh are testing a vaccine to recognize a protein in colon polyps and trigger the immune system to destroy them.

MUC1 is a protein found in precancerous colorectal polyps and in colon cancer. The experimental vaccine causes the body’s immune system to develop antibodies against MUC1, killing tissue that contains it and potentially preventing polyps from returning. Read the rest of this entry »

You may have heard the very exciting data about patients with breast cancer who carry BRCA mutations. These mutations indicate a genetic predisposition for breast cancer.

The function of BRCA is DNA repair, very similar to the genes associated with familial colorectal cancer known as Lynch syndrome or HNPCC (hereditary nonpolyposis colon cancer) which are the DNA mismatch repair genes. Read the rest of this entry »