September 27, 2007

BIRMINGHAM, Ala. – New clinical data showed an experimental drug called pertuzumab prolonged the survival time for women with recurrent ovarian cancer, a University of Alabama at Birmingham doctor said recently.

The data was presented Sept. 24 during a scientific session of the 14th European Cancer Conference held in Barcelona, Spain. The session’s main speaker was Sharmila Makhija, M.D., an associate professor in UAB’s Division of Gynecologic Oncology.

Makhija said Phase II clinical trial data showed that pertuzumab added weeks to the lives of Stage 3 ovarian cancer patients whose disease had returned after treatment with existing chemotherapy regimens.

In the study, pertuzumab was administered in combination with a standard chemotherapy agent sometime after the initial treatments had been given, and after the re-emergence of cancer. Makhija said the new combination added weeks to the standard survival period for recurrent patients, and the drug combo was well-tolerated by the body and caused minimal side effects.

“We wanted to know if pertuzumab would improve the effects of the chemotherapy with cancer recurrence, and if it would improve their lives. It did,” Makhija said. “Now we want to see if it impacts overall survival.”

Once ovarian cancer becomes resistant to multiple types of chemotherapy, fewer treatment options exist and the focus becomes lengthening patients’ survival periods.

The pertuzumab trial included 130 women enrolled by UAB, Dana-Farber Cancer Institute and Dana-Farber/Brigham and Women's Cancer Center in Boston, University of Kentucky Chandler Medical Center’s Markey Cancer Center in Lexington, Women and Infants’ Hospital of Rhode Island in Providence, Sharp Rees-Stealy Medical Group in San Diego, University of Oklahoma Health Sciences Center in Oklahoma City. Study costs were paid by Genentech Inc. in South San Francisco, Calif.

Makhija presented the same results earlier this year at the 2007 American Society of Clinical Oncology meeting in Chicago.

Makhija said the Phase 2 study is now closed, and researchers are in the planning stages for a larger Phase 3 study of pertuzumab set to include hundreds of U.S. women.

Pertuzumab is approved only for experimental uses. It falls within a class of anticancer agents called monoclonal antibodies. Such drugs target key signaling pathways within cells that can stop or slow tumor growth.