The "encouraging" results merit development of a larger, randomized trial, says the study leader, Edward Kim, M.D., of The University of Texas M. D. Anderson Cancer Center.
The Phase II clinical trial was conducted at M. D. Anderson, the University of Chicago and Arlington Cancer Center.
The study is the only one to test a cocktail of docetaxel chemotherapy and C225 for second-line treatment after patients stop responding to initial chemotherapy. All patients had advanced non-small cell lung cancer that was progressing from their original therapy.
In the study, one patient had a complete response; 11 patients had a confirmed partial response (tumor shrinkage that lasted at least several months and was verified using a diagnostic CAT scan); one patient had an unconfirmed partial response (this patient died of unrelated causes before the response could be verified); and 18 patients had disease stabilization. Five patients still remain on the study, some of whom have been treated with more than 20 tri-weekly cycles of C225.
By the most conservative estimate, this means tumors shrank in one-quarter (25.5 percent) of patients in this trial, whereas median response in second-line therapy is generally 5 percent to10 percent, according to Kim, an assistant professor in the Department of Thoracic/Head and Neck Medical Oncology. That response is not likely due to the use of docetaxel, given that a large Phase III trial of this docetaxel as second line therapy found a response rate of just 6 percent.
"This is not a home run, but the results are promising," he says. "This is the best response rate we have seen in combination, second-line therapy for this advanced cancer."
C225, an experimental biological treatment that blocks EGF and other molecules that promote growth from sticking to the surface of cancer cells and tumors, is being tested in other cancers, including colon and head and neck malignancies. Docetaxel is currently approved for treatment of various cancers including lung cancer and breast cancer.
Contact: Laura Sussman or Stephanie Dedeaux, (713) 792-0655