A Comparison of 2 Standard Doses of Bevacizumab in Combination With Chemotherapy in Epithelial Ovarian Cancer
Trial Parameters
Brief Summary
A pragmatic, two armed, study comparing 2 standard doses of an anti-cancer drug called bevacizumab, given in combination with Chemotherapy. The study will be offered to ovarian cancer patients whose disease is platinum chemotherapy resistant . Higher doses of anti-cancer based drugs are not always better than lower doses and can cause more side effects without improvement of cancer. These patients will be randomly assigned either 7.5 mg/kg or 15mg/kg of bevacizumab combined with chemotherapy . Comparing these two doses will determine if the lower dose-level is non-inferior, and could lead to practice changes.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal, or fallopian tube carcinoma according to WHO Classification of tumours that is advanced/metastatic/recurrent or unresectable and for which no curative therapy exists. * Platinum resistant disease (progression within six months of completing a platinum-containing protocol). In this case, progression from the last line of therapy would be defined as radiologic progression by RECIST 1.1 criteria on CT or MR. * Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days of randomization. * All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows: * Chest x-ray \> 20 mm * CT scan (with slice thickness of 5 mm) \> 10 mm longest diameter * Physical exam (using calipers) \> 10 mm Lymph nodes by CT scan \> 15 mm measured in short axis * Patients must be \>= 18