Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Evaluation of the Efficacy of Sunitinib® in Patients With Recurrent Ovarian Clear Cell Carcinoma
Brief Summary:
Patients with early and advanced stages of epithelial ovarian cancer are treated with postoperative systemic chemotherapy after appropriate surgical staging and cytoreductive surgery. For ovarian cancer patients with recurrence, salvage chemotherapy with or without secondary cytoreductive surgery are recommended. The recommendation for specific primary adjuvant or salvage chemotherapy is cyclophosphamide or paclitaxel plus platinum regimens. Despite the high objective response rate associated with primary chemotherapy in ovarian cancer, the majority of patients will eventually experience disease recurrence and be potential candidates for a second-line treatment approach.
Ovarian clear cell adenocarcinoma (OCCA) is recognized as a distinct histological type of cancer in the WHO-classification of ovarian tumors. OCCA is thought to arise from endometriosis and most patients present with the disease at early stages (International Federation of Gynecology and Obstetrics (FIGO) stages I and II). The incidence of OCCA among epithelial ovarian cancers is estimated to be less than 5-10%. However, OCCA occurs more frequent in Japan and Taiwan (around 10-15%). Unfortunately, OCCA is usually more resistant to systemic chemotherapy than other types and has a poorer prognosis.
Sunitinib is a small molecule with anti-tumor properties pharmacologically mediated through inhibition of multiple receptor tyrosine kinase (RTKs), which are important regulators of tumor cell growth, angiogenesis, and metastasis. Due to its multi-targeted profile, the pharmacological activity of sunitinib is likely mediated by inhibition of multiple RTK targets and multiple pathways. c-KIT has been implicated in mastocytosis/mast cell leukemia, germ cell cancers, small-cell lung cancer, GISTs, AML, neuroblastoma, melanoma, and ovarian and breast carcinoma. In add