Full TitleA Phase I Study Of Intravenous Carboplatin/Paclitaxel Or Intravenous And Intraperitoneal Paclitaxel/Cisplatin In Combination With Continuous Or Intermittent/CTEP-Supplied Agent ABT-888 (NSC #737664) And CTEP-Supplied Agent Bevacizumab (NSC #704865) In Newly Diagnosed Patients With Previously Untreated Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Cancer(GOG 9923) Back to top
The purpose of this Gynecologic Oncology Group study is to evaluate the safety and effectiveness of various dosing regimens of an investigational drug called ABT-888 when given with carboplatin, paclitaxel, and bevacizumab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not had chemotherapy.
ABT-888 kills cancer cells by preventing the repair of DNA or genetic damage in cancer cells, possibly making them more susceptible to anticancer drugs. It can also work well in cancer cells that do not have functional BRCA, a protein which helps to fix DNA damage. About 10 percent of ovarian cancer patients have an inherited defect in BRCA.
Carboplatin and paclitaxel are used routinely to treat these cancers. Bevacizumab is approved for the treatment of other cancers; its use in these cancers is considered investigational.Back to top
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have newly diagnosed stage II, III, or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Patients may have had surgery (4 or more weeks before study entry) but not prior chemotherapy or radiation therapy for their disease.
- Patients must be age 18 or older.