A randomized phase II evaluation of weekly paclitaxel (NSC#673089) versus weekly paclitaxel with oncolytic reovirus (reolysin NSC#729968, BB-IND# 13370) in the treatment of recurrent or persistent ovarian, fallopian tube or primary peritoneal cancer.
A variety of chemotherapy options exist for patients who have been diagnosed with ovarian, fallopian tube or primary peritoneal cancer. Paclitaxel is one such agent that when given weekly is associated with reduction in the growth of ovarian cancer in many women with mild side effects. However, newer classes of drugs in combination with weekly Paclitaxel need to be studied with this disease. REOLYSIN, a virus that is present throughout the environment and typically affects individuals with flu-symptoms, has been shown to target cancer cells helping to decrease the size of tumors. The purpose of this study is to compare the effectiveness and safety of REOLYSIN and weekly paclitaxel, compared with paclitaxel alone.
- Be at least 18 years old
- Have had at least one prior platinum-based chemotherapy regimen
- Patients who have received only one prior cytotoxic regimen, must have a platinum-free interval of less than 12 months, or have progressed during platinum based therapy, or have persistent disease after a platinum-based therapy.
- Have adequate bone marrow function, renal function, hepatic function, neurologic function
- Have a negative pregnancy (if of child bearing age)
- Be able to avoid direct contact with pregnant or nursing women-infants and immunocompromised individuals while on study and for more than 3 weeks following the last dose of REOLYSIN administration.
Janet L. Osborne, M.D.
Vickie Yates, RN
Clinical Research Nurse Coordinator