What we are studying
The purpose of this study is to find out if REOLYSIN® works in treating your type of cancer and to find out what side effects are caused by treatment with this drug.
Chemotherapy is the standard treatment for cancer of the ovary, fallopian tube or peritoneum when it returns after initial treatment and is not curable. A number of chemotherapy options exist for patients when their cancer grows despite treatment with the most effective chemotherapy (such as carboplatin or cisplatin). One of these agents is paclitaxel, which when administered weekly (rather than every 3 weeks) is associated with reduction in the growth of ovarian cancer in many women, and is associated with relatively mild side effects. However, newer classes of drugs in combination with weekly paclitaxel need to be studied in this disease.
REOLYSIN® is a virus that is present throughout the environment and has affected most individuals with flu-symptoms, but is not associated with any long-term effect. Previous research has shown this virus has been shown to target cancer cells more actively than normal cells, and thus has been shown to decrease the size of cancers and improve cancer related symptoms in patients with a variety of solid tumors such as head and neck cancers, colon cancers and lung cancer. However, REOLYSIN® is not approved by the U.S. Food and Drug Administration (FDA), and is being extensively studied in cancer patients in the U.S. and around the world. However, the experience using REOLYSIN® in patients with ovarian, tubal and peritoneal cancer is limited. It is very important to understand that REOLYSIN® is experimental in this study.
The purpose of this research study is to compare the effectiveness and safety of (1) REOLYSIN® and weekly paclitaxel, compared with (2) paclitaxel alone. Thus, there are two “arms” of this study.