The PACOVAR-trial: A phase I/II study of pazopanib (GW786034) and cyclophosphamide in patients with platinum-resistant recurrent, pre-treated ovarian cancer

This study is designed as a multicenter phase I/II trial evaluating the optimal dose for pazopanib (phase I) as well as activity and tolerability of a combination regimen consisting of pazopanib and metronomic cyclophosphamide in the palliative treatment of patients with recurrent, platinum-resistant, pre-treated ovarian cancer (phase II). The patient population includes patients with histologically or cytologically confirmed diagnosis of EOC, cancer of the fallopian tube or peritoneal cancer which is platinumresistant or -refractory. Patients must have measurable disease according to RECIST criteria and must have failed available standard chemotherapy. Primary objectives are determination of the optimal doses for pazopanib (phase I) and the overall response rate according to RECIST criteria (phase II). Secondary objectives are time to progression, overall survival, safety and tolerability. The treatment duration is until disease progression or intolerability of study drug regimen (with a maximum of 13 cycles up to 52 weeks per subject).The current phase I/II trial shall clarify the potential of the multitargeting antiangiogenic tyrosinkinaseinhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage treatment in patients with recurrent, pretreated ovarian cancer.ClinicalTrials.gov: NCT01238770About 8,200 women a year in Germany develop a malignant tumour of the ovary. The incidence of ovarian carcinoma has remained unchanged in the last few decades [1]. With more than 6,000 deaths, it is the fifth highest cause of cancer-related mortality in women [2]. Symptoms of the disease usually develop at a very late stage. For this reason about 70% of patients are already in an advanced stage of the tumour at the time of diagnosis (FIGO III or IV). Surgical tumour removal is the primary treatment. Whether and to what extent residual tumour formation is present postoperatively is the deciding factor in the subsequent prognosis for the patient. After s