Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Antineoplastic Agents

Celecoxib

Epothilone B

Epothilones

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

EPO906 IV, every three weeks, celecoxib by mouth twice a day every day

EPO906, celecoxib

Heinz-Josef Lenz, M.D.

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.

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

Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer (CEPO906AUS10)

Novartis

University of Southern California

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer	NCT00159484	Colon Cancer Colorectal Canc...	EPO906, celecox...	18 Years -	University of Southern California
Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer	NCT00159484	Colon Cancer Colorectal Canc...	EPO906, celecox...	18 Years -	University of Southern California

Spots Global Cancer Trial Database for epo906, celecoxib