Optimizing Chemotherapy with Bevacizumab for Ovarian Cancer
Name of the Trial
Phase III Randomized Study of Bevacizumab in Combination with Intravenous Versus Intraperitoneal Chemotherapy in Patients with Stage II, III, or IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Carcinoma (GOG-0252). See the protocol summary.
Dr. Joan Walker, Gynecologic Oncology Group
Why This Trial Is Important
Women with ovarian cancer usually undergo surgery to determine the cancer's stage and to remove as much malignant tissue as possible. Following surgery, these women are treated with chemotherapy in an effort to eliminate remaining cancer cells.
Typically, chemotherapy for ovarian cancer is administered intravenously (IV) and travels throughout the body in the blood (systemic chemotherapy). Research by the Gynecologic Oncology Group and others, however, has demonstrated that combining IV chemotherapy with the delivery of chemotherapy drugs directly into the peritoneal cavity (intraperitoneal, or IP, chemotherapy) is more effective in delaying cancer progression and helping patients live longer. Since tumors are often confined to the peritoneal cavity in patients with ovarian cancer (as well as in those with fallopian tube or primary peritoneal cancer, which are biologically similar diseases), IP chemotherapy may allow for a greater concentration of anticancer drugs in the area around the tumors while limiting side effects elsewhere in the body. Results published in 2006 from a phase III trial showing a median increase in survival of 12 months for women treated with IV plus IP chemotherapy led NCI to issue a clinical announcement encouraging use of the combined treatment.
Other recent developments in the treatment of ovarian cancer may offer benefits similar to those seen with IV plus IP chemotherapy while avoiding some of problems associated with it (such as increased toxicity and difficulty of administration). A recent phase III study using the chemotherapy drug paclitaxel intravenously on a weekly basis, along with IV carboplatin given every 3 weeks, yielded improvements in progression-free and overall survival compared to the same drugs given every 3 weeks. Additionally, treatment with the angiogenesis inhibitor bevacizumab has shown significant antitumor activity in phase II studies.
- IV paclitaxel weekly and IV carboplatin every 3 weeks
- IV paclitaxel weekly and IP carboplatin
- IV paclitaxel and IP cisplatin, followed by IP paclitaxel
All patients will receive IV bevacizumab during and following chemotherapy. Doctors want to know which of these three regimens is most effective in delaying progression and improving survival.
"This trial is designed to determine if IP therapy is still superior given the clinical advances seen with regimens using weekly IV paclitaxel and/or bevacizumab," said Dr. Walker. "The added benefit of weekly IV paclitaxel and bevacizumab, in combination, for women with ovarian cancer has the potential to be a very exciting advance."