Ovarian Cancer Clinical Trials
Clinical trials are designed to research, evaluate and scientifically prove whether a new drug, treatment, or combination of treatments is safe, effective and possibly better than the current standard-of-care. Nearly all cancer drugs in use today were tested and made available to patients through clinical trials.
Clinical trials are for all patients, but for those whose cancer has not responded to standard treatments, they may be the best available treatment option. Those who participate in clinical trials have the first chance to benefit from new therapies in development, while also playing a role in advancing the standard of care for future patients.
Epithelial ovarian tumors that are malignant are called “carcinomas” contributing to 85% to 90% of ovarian cancer cases.
Ovarian cancer ranks fifth in cancer deaths among women and the lifetime risk of ovarian cancer is about 1 in 75. It mainly occurs in older women and about half of those diagnosed are over the age of 63. There have been many relatively recent breakthroughs in ovarian cancer research and the death rate from ovarian cancer has fallen over the past 20 years, due in large part to clinical trial advancements. However, awareness-raising efforts, particularly during October—Ovarian Cancer Awareness Month, have also helped. However, there are still many opportunities to study and learn more about ovarian cancer in the hopes of finding better treatments – and possibly even a cure.
Ovarian cancer arises from ovarian cells that have grown out of control or mutated. The ovaries have several cell types, including epithelial cells, which are the cells on the outer surface of the ovaries; germ cells, which are the cells that produce the eggs; and stromal cells, which are the tissue cells that provide structure and produce hormones. The majority of ovarian tumors form at the epithelial cell level, but most are benign (non-malignant). Some epithelial tumors are characterized as “low malignant potential,” because they usually do not grow past the epithelial cells into the rest of the ovary. This tumor type is more common in younger women and grows slowly.
Epithelial ovarian tumors that are malignant are called “carcinomas” and represent 85% to 90% of all ovarian cancers. There are four types of ovarian carcinomas, including serous (most common), mucinous, endometrioid, and clear cell. If the tumor is not one of these four types, then it is defined as “undifferentiated” and more likely to be a faster growing tumor. Tumors are further classified into grades according to how closely it resembles normal tissue with Grade 1 appearing more like normal tissue and Grade 3 appearing less like normal tissue. Tumors are also given a stage which describes the degree of spread. Germ cell tumors originate in the cells that form the eggs and represent fewer than 2% of ovarian cancerous tumors and stromal cell tumors represent about 1%. Learn more from the American Cancer Society
History of Ovarian Cancer
On Christmas Day 1809, Jane Todd Crawford had an astonishing 22-pound tumor extracted from her abdomen. As the first documented case of ovarian tumor removal, the event holds a significant place in medical history. Since that time, ovarian cancer research has made significant leaps, especially within the past 30 years, which have seen tremendous advances in the screening, diagnosis, and treatment of ovarian cancer. Despite this progress, there are still many unanswered questions and much to be learned about the disease.
One of the most common and heavily researched diagnostic tools in use today is screening women for elevated levels of the blood protein CA-125. Robert Bast, MD, vice president for translational research at the University of Texas M. D. Anderson Cancer Center, first discovered the biomarker in 198.1. Dr. Bast asserts that although the CA-125 blood test is on par with mammography in terms of cost-effectiveness and potential years of life saved, it is far from perfect.
One of the biggest problems with using CA-125 as a screening tool is the tendency of the marker to be elevated in women who do not have ovarian cancer—a phenomenon referred to as a false positive.
Dr. Bast notes that another problem with relying solely on CA-125 is that levels tend to fluctuate over time and start to rise approximately two years before early diagnosis can be made. Therefore, at-risk women need to be screened repeatedly—usually once a year for several years. Even then, though, he points out that CA-125 will not consistently predict cancer progression, making research about the usefulness of screening measures even more necessary.
Some the most promising evidence to support screening comes from the UK Collaborative Trial of Ovarian Cancer Screening, which followed 200,000 women in London, England for a median period of roughly 11 years. Study researchers were able to demonstrate that routine use of CA-125 or vaginal ultrasound resulted in 48 percent of ovarian cancers being diagnosed at Stage I or II. Carmel Cohen, MD, professor of gynecological oncology at the Mount Sinai School of Medicine in New York City and scientific director of the Ovarian Cancer Research Fund, believes that the importance of this finding cannot be understated.
Because a single test has yet to be proven definitive in detecting early-stage ovarian cancer with one hundred percent certainty, researchers are also considering alternative methods, such as examining patterns of abnormal proteins (called proteomic techniques). High levels of osteopontin, a protein expressed in bone and other tissues, in conjunction with elevated CA-125, for example, may be more indicative of disease than looking at either separately. Assessing panels of as many as six proteins simultaneously may become the standard. Proteomic research is complex and still in its infancy, but it appears to hold promise.
But will screening really have an impact on prognosis? In an attempt to answer that question, Dr. Bast and his research team are conducting a smaller-scale version of the UK screening trial to see how useful CA-125 and ultrasound screening are in early diagnosis and the impact of this type of screening on disease course and outcome.
Current Ovarian Cancer Research
Ovarian cancer treatment during the past 40 years has improved because of clinical trials. The big breakthrough for ovarian cancer came in the 1970s with the use of cisplatin as a chemotherapy after clinical trials showed it effectiveness. Other drugs used at that time extended life for a little more than a year, while cisplatin improved life expectancy for a much longer time. Unfortunately, with the use of cisplatin, ovarian cancer patients started developing nerve and kidney damage.
Clinical trials in the 1980s revealed that carboplatin was a less toxic version of cisplatin and it became the treatment of choice. In the 1990s, clinical trials showed that combining carboplatin and taxol increased survival and the combination became the standard of care. More recent clinical trials have led to the 2006 standard of care that recommends administering chemotherapy into the abdominal cavity and intravenously for women with a subset of women with advanced ovarian cancer.
Many ovarian cancer clinical trials are also ongoing today. One tests whether avastin, a drug that stops new blood vessels from growing and is currently used to treat other cancers, might be effective in ovarian cancer. Another trial is testing whether giving taxol once a week might be more effective than giving it every three weeks. Learn more from the Ovarian Cancer Research Fund
A wealth of new evidence has broadened our understanding of risk factors that may increase a woman’s chance of developing ovarian cancer. This is critical information because awareness of risk increases patients’ likelihood of receiving early treatment. Doctors have long known that being over the age of 50; having a family history of ovarian, breast, or colorectal cancer; and having no history of childbirth are the most common risk factors for the disease. More recent research, however, has focused on reproductive and hormonal factors. Learn more from CancerConnect.com
More recent ovarian cancer research is focusing on reproductive and hormonal factors in addition to known risk factors.
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