Gynecologic oncology group trials in ovarian carcinoma

The Gynecologic Oncology Group (GOG) is performing a series of trials in patients with all stages of epithelial ovarian cancer to examine the role of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) given either as a single agent or in combination with a platinum compound. The previous completed pivotal GOG study (GOG 111) demonstrated that combined paclitaxel/cisplatin was superior to the then-standard regimen of cyclophosphamide/cisplatin. Based on the results of GOG 111, cisplatin (75 mg/m2) together with paclitaxel (135 mg/m2 by 24-hour infusion) became the new GOG standard regimen. Similarly, GOG protocol 9202 demonstrated that carboplatin could be combined with paclitaxel at full therapeutic doses. In patients with early stage ovarian cancer, an ongoing randomized trial is comparing three versus six cycles of paclitaxel (175 mg/m2 by 3-hour infusion) together with carboplatin (dosed to an area under the concentration-time curve of 7.5). In patients with optimal stage III disease, the randomization is between standard cisplatin/paclitaxel versus carboplatin/paclitaxel. Two trials are in progress in patients with suboptimal stage III and IV disease. In the highest priority trial, patients receive three cycles of paclitaxel/cisplatin and are randomized to undergo interval debulking surgery, followed by an additional three cycles of the same chemotherapy, or to no interval debulking surgery and continuation of paclitaxel/cisplatin chemotherapy. Patients not eligible for this trial are randomized to receive standard cisplatin/paclitaxel or to an experimental arm of paclitaxel (120 mg/m2 in a 96-hour infusion) combined with cisplatin (75 mg/m2). Additional trials in relapsed patients are examining the importance of dose intensity of paclitaxel and the potential therapeutic value of intraperitoneal paclitaxel.