A new targeted, "silver bullet" drug is being given to women with ovarian cancer to improve their survival as part of a new study by an Oregon Health & Science University researcher and surgical oncologist.
The drug, Telcyta, has been shown in animal studies to be effective in fighting ovarian cancer in subjects that are resistant to platinum, one of the best drugs to combat ovarian cancer. About 30 percent of women with ovarian cancer are resistant to platinum and have recurring ovarian cancer. Telcyta works by binding to the platinum drug, releasing a reactive fragment of the platinum and then bombarding the cancer cell, which causes the cancer cell to die.
Fabio Cappuccini, M.D., principal investigator of the study, described how Telcyta works: "The platinum drug is like the quarterback and Telcyta acts like a defensive lineman, removing the opponents in the way so that the quarterback (platinum) can make the touchdown, causing the cancer cell's death." Cappuccini is chief of the Division of Gynecologic Oncology, assistant professor of obstetrics and gynecology, OHSU School of Medicine. He is a member of the OHSU Center for Women's Health and the OHSU Cancer Institute, which is supporting the study.
"This drug is drawing a lot of attention. It is targeting a population of patients without a lot of hope. I have a lot of hope in this drug," said Cappuccini.
The randomized, Phase 3 study builds on the results of previous Phase 2 studies. The side effects of the drug have been minor and include mild nausea, vomiting and headaches. The drug is given intravenously every three weeks for a total of six cycles. Participants not getting Telcyta are given Doxil, which is the standard drug given to currently to platinum-resistant patients. Only about 6.5 percent to 12 percent of patients respond to Doxil.
This multi-site clinical trial is being conducted at OHSU and at Kaiser Permanente where Cappuccini is chief of gynecological oncology services. Seventy centers throughout the country are testing Telcyta. So far, four participants have enrolled in the OHSU and Kaiser studies. The study is still open, and Cappuccini is looking for several more research subjects.
The current treatment for advanced ovarian cancer is the surgical removal of the reproductive organs, followed by chemotherapy. If the cancer recurs following chemotherapy, it is difficult to treat. It is hoped that Telcyta will offer a new approach for women with advanced ovarian cancer.
Ovarian cancer strikes more than 25,000 women in the United States each year and kills more than 16,000 women, according to the American Cancer Society. Ovarian cancer is called the silent killer because in its early stages there are few signs or symptoms. In more than 70 percent of cases, ovarian cancer is detected only after it has spread from the ovaries to other parts of the body, where symptoms become evident. Pap tests do not detect ovarian cancer. The symptoms are vague, but include: swelling of the stomach from a buildup of fluids, unusual vaginal bleeding, pelvic pressure, back or leg pain and problems such as gas, bloating, long-term stomach pain or indigestion.
The study is being funded by Telik, Inc., a biopharmaceutical company dedicated to discovering, developing and commercializing novel small-molecule drugs to treat cancer and other serious diseases.
The OHSU Center for Women's Health is a nationally designated Center of Excellence. This designation supports OHSU and the OHSU Center for Women's Health's expertise and continued commitment to perform exemplary clinical care, research, community outreach, professional education and leadership.
The OHSU Cancer Institute is the only National Cancer Institute-designated cancer center between Sacramento and Seattle. It comprises some 120 clinical researchers and basic scientists who work together to translate scientific understanding into longer and better lives for people living with cancer. It has established an ovarian and breast cancer research group seeking to develop newer less toxic approaches to the management and prevention of breast and ovarian cancer. In the lab, basic scientists examine cancer to uncover molecular abnormalities that cause disease. This basic science is supported by more than 200 open clinical trials that test in patients what's been proved in the laboratory.