Cincinnati—A University of Cincinnati (UC) gynecologic oncology expert is testing an investigational drug he hopes will lead to more effective treatments for recurrent ovarian cancer, an often aggressive and difficult-to-diagnose form of cancer that affects more than 21,000 women in the United States annually.
W. Edward Richards, MD, is leading the local arm of a phase-2 clinical trial—known as Precedent—to evaluate a new type of chemotherapy, drugs that kill cancer cells.
Known only as EC145 while in testing, the investigational drug is designed to deliver a potent dose of chemotherapy to specific cells linked to ovarian cancer with minimal side effects to the patient.
Standard-of-care for ovarian cancer typically begins with surgery to remove as much abdominal/pelvic tumor as possible followed by a two-drug platinum-based chemotherapy regimen to destroy residual cancer cells.
Richards says many patients with stage-3 and stage-4 ovarian cancer relapse within six months of treatment, making additional platinum-based chemotherapy treatments less effective in controlling cancer’s spread.
“We are in dire need of alternative therapies for ovarian cancer when standard-of-care fails,” explains Richards, a gynecologic-oncologist/surgeon and director of women’s cancer for UC Physicians and University Hospital. “There are no effective universal screening tests for ovarian cancer, 75 percent of patients are diagnosed with advanced disease and nearly all patients with advanced disease experience a cancer recurrence.”
To be eligible for the trial, women must have ovarian, fallopian tube or peritoneal cancer that progressed in less than six months of their first or second treatment with a platinum-based chemotherapy drug. All study participants will receive pre-treatment imaging scans to help monitor disease response to medical therapy.
Trial participants will be placed at random into one of two treatment groups. The first group will receive a combination of standard second-line chemotherapy (doxorubicin liposomal, pronounced dox-oh-REW-beh-sin lye-poe-SEW-mull) and the investigational EC145 drug. The second group will not receive the investigational EC145 drug and will just receive the standard second-line chemotherapy.
Research has shown that both normal and cancer cells need the vitamin folate or folic acid (B-9) to function. Certain rapidly dividing cancer cells, including ovarian, need more folate to thrive than the surrounding normal cells. These folate-craving cancer cells have special properties that allow them to capture the vitamin as it moves through the bloodstream, feeding the abnormal cell’s growth.
Based on this scientific premise, the EC145 chemotherapy agent is attached to folate to essentially trick the cancer cell into absorbing the drug, thinking it is folate alone. Researchers believe the cancer cells will be attracted to the folate included in EC145 and absorb it into the cell.
“Once the drug is absorbed into the cell, it will link the anti-cancer agent to the cancer cell and should result in targeted cancer cell death. If this proves effective in the clinic, it would allow us to deliver highly targeted chemotherapy to the affected tissues without causing damage to healthy cells,” explains Richards, an associate professor of gynecologic oncology at the UC College of Medicine.
He says this new trial is an exciting prospect for ovarian cancer care: “Improving therapy effectiveness while also minimizing side effects could help us improve a patient’s chances of survival and give them a higher quality of life.”
For eligibility information for this and other UC gynecologic oncology trials, call Tonia Wilson at (513) 584-5044. The Precedent trial is recruiting patients at the UC Barrett Cancer Institute at University Hospital, located in Clifton, and UC Physicians medical sites in Clifton and West Chester. For regular patient appointments with Richards, call (513) 584-6373.
UC is the only center offering the investigational treatment within a 100-mile radius of Cincinnati. Precedent is sponsored by Endocyte, Inc., maker of the investigational drug EC145. Richards has no financial interest in the company.
The UC Barrett Cancer Institute at University Hospital is part of the Cincinnati Cancer Consortium, a joint cancer program involving the UC College of Medicine, Cincinnati Children’s Hospital Medical Center and University Hospital. The collaborative initiative brings together interdisciplinary research teams of caring scientists and health professionals to research and develop new cures, while providing a continuum of care for children, adults and families with cancer.
About Clinical Trials and Patient Participation
Clinical trials are research studies that test how well new medical approaches work in people. Every trial has a set of medical guidelines (known as a protocol) which describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Patients who choose to participate in a clinical trial go through a process known as informed consent where they learn the important facts about a clinical trial to help them decide whether to participate. Payment of patient care costs in clinical trials varies by health insurance plan and by study. (Source: National Cancer Institute)