Researchers are now investigating whether the human reovirus, when prescribed along with chemotherapy, will provide a desperately needed “one-two punch” against ovarian cancer. The news comes during the month of September, which is National Ovarian Cancer Month. The American Cancer Society estimates that 21,880 American women will be diagnosed with ovarian cancer and an estimated 13,850 will die from the disease in 2010.
Ovarian cancer accounts for about 3% of all cancers among women and ranks second among gynecologic cancers. The prognosis for patients diagnosed with ovarian cancer at the localized stage is good with a five-year survival rate of 94%; however, fewer than 15% of cases are diagnosed at this stage. The relative 10-year survival rate for all stages combined is approximately 38%.
Calgary-based Oncolytics Biotech Inc. recently announced that the Gynecologic Oncology Group (GOG) intends to conduct a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN® in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (GOG186H).
The GOG is a non-profit national organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies.
The study has been approved and will be sponsored by the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, US National Cancer Institute (NCI), which is part of the National Institutes of Health, under its Clinical Trials Agreement with Oncolytics.
According to the lead chair on the study, Dr. David E. Cohn of The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, “Ovarian cancer is typically diagnosed at the later stages, because earlier stage disease usually has no obvious symptoms. On this basis, surgical interventions used in earlier stages are often supplemented by chemotherapy; however, there are limited treatment options for patients with recurrent disease.”
Dr. Brad Thompson, President and CEO of Oncolytics, says the primary objectives of the trial are to estimate the progression-free survival hazard ratio of the combination of weekly paclitaxel with REOLYSIN to weekly paclitaxel alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer, and to determine the frequency and severity of adverse events associated with treatment with weekly paclitaxel alone and weekly paclitaxel with REOLYSIN as assessed by Common Terminology Criteria for Adverse Events (CTCAE).
The secondary objectives are to estimate the progression-free survival and overall survival of patients treated with weekly paclitaxel alone and weekly paclitaxel with REOLYSIN, and to estimate and compare the proportion of patients who respond to the regimen on each arm of the study. The study is expected to enroll up to 150 patients.
“Oncolytics is pleased to be collaborating with the NCI and GOG as they push forward innovative research initiatives utilizing REOLYSIN. Relationships with these groups allow us to broaden our clinical program to include additional indications and, in this case, conduct our first randomized Phase II study,” says Dr. Thompson.
Source: Oncolytics Biotech