AGO-Cervix-1 study: A prospective, randomized phase III study to compare the effects of Paclitaxel and Topotecan to those of Cisplatin and Topotecan for treatment of patients with recurrent or persistent cervical cancer

In patients with recurrent, persistent, or metastasized cervical cancer for which a curative treatment by operation and/or radiation therapy is not possible chemotherapy is an option. But up to 75% of all these patients are assumed to have already been treated with cisplatin in conjunction with radiation therapy. It seems questionable to continue to treat the patients with cisplatin. The studies GOG 169 and 179 demonstrated that a combination of paclitaxel and cisplatin was superior to a cisplatin monotherapy with respect to therapeutic response and progression-free survival, as was a combination of topotecan and cisplatin with respect to therapeutic response, progression-free survival, and total survival. To achieve further improvement in total survival and to answer questions regarding the value of using a platinum-free combination, the AGO-Cervix-1 study was started in December 2006. The study compares the efficacy of a platinum-free combination of paclitaxel (70mg/m²) and topotecan (1.75mg/m²), d1,8,15, q28d to a combination of cisplatin (50mg/m²), d1 and topotecan (0.75mg/m²), d1–3, q21d. Chemotherapy is given for six cycles or for nine cycles in response or stable disease. 312 patients will be randomized in the two study arms. Until now 28 patients could be registered. 55 cycles already could be administered. There were eleven serious adverse events: twice febrile leucopenia, once leukopenia, once hemorrhoids bleeding, thrice reduced general condition, once subileus, once hydronephrosis and once enterocutaneous fistula.