The study was part of the Specialized Program of Research Excellence (SPORE) in lung cancer at UCLA's Jonsson Cancer, a program funded by the National Cancer Institute at top research institutions nationwide to find better and more effective ways to prevent, detect and treat lung cancer.
"This trial is an important early step in utilizing combination targeted therapies in lung cancer," said Dr. Steven Dubinett, director of UCLA's lung cancer SPORE and a professor of pulmonary and critical care medicine. "Dr. Reckamp's trial is the first to study increasing doses of a COX-2 inhibitor in lung cancer in an attempt to define an optimal biological dose. Larger trials of combination therapies utilizing this dose will now be required."
The biology of an individual's tumor determines whether they will respond to Tarceva. Because researchers don't yet fully understand what biologic characteristics determine response, they can't test patients first to determine who should be given the drug. Since 90 percent of patients don't respond to Tarceva, the drug was not an option for them. Reckamp said a portion of those may now be able to take Tarceva combined with Celebrex.
Because they target what is broken in a cancer cell and leave the healthy cells alone, therapies like Tarceva cause fewer side effects than conventional therapies such as chemotherapy, which targets all fast growing cells and often results in debilitating side effects. Reckamp characterized the side effects seen with the combination therapy as minor.
The next step is a larger Phase II study to confirm the efficacy of the combination therapy and further probe the mechanisms of Tarceva resistance, Reckamp said. That study is expected to begin at UCLA in the fall.
Reckamp's study was the first to determine the safest and most effective dose of Celebrex to use in lung cancer. Previously, doses were based on studies done in colon cancer patients.'"/>