Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer

This study is for people with advanced colorectal cancer. This study uses the drugs
Celebrex and EPO906. EPO906 is an experimental drug that has not been approved by the FDA.
EPO906 is a drug that has been shown in the laboratory to cause cancer cells to die and
prevents them from growing and reproducing. Celebrex is a drug that is approved by the FDA
for the treatment of arthritis and prevention of colon polyps. Colon polyps are small
growths in the colon. If not surgically removed, some colon polyps can become cancerous.
Some studies have shown that Celebrex may reduce the side effects of chemotherapy. Other
studies have shown that it may increase the effectiveness of some chemotherapy. Celebrex is
not approved by the FDA for reducing the side effects of chemotherapy or improving the
effectiveness of chemotherapy. The combination of EPO906 and Celebrex in this study is
experimental.

The main goal of this study is to see if adding the drug Celebrex to the drug EPO906 will
decrease the amount of diarrhea seen in patients that receive EPO906.

The goal of the first phase of this study is to find the highest dose of EPO906 that can be
given safely with Celebrex. The dose of Celebrex will remain the same for the whole study.
Higher doses of EPO906 will be given to each group of patients. The increase of EPO906 will
stop once more than one patient has serious side effects. The highest dose of EPO906 that
can be given with Celebrex (without serious side effects) will be called the pilot dose.

The goal of the second phase of this study is to find out how tumors respond to these doses
of the drugs. Another purpose of this study is to see how the body processes the EPO906 and
Celebrex. This study will also look at the side effects of these drugs. In this study, we
will measure how long subjects live, how often tumors shrink after receiving the study
drugs, and how long it takes for tumors to increase in size after receiving the study drugs.
This study will also measure the levels of genes, which are the cell's blueprint, in
participant's tumors. Several genes can affect how people's bodies react to the cancer
drugs. Genes will also be measured in participant's blood. We want to see if these predict
response to the study drugs.