Sunitinib® in Patients With Recurrent Ovarian Clear Cell Carcinoma
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
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 addition, sunitinib has demonstrated a higher response rate than
that reported for anti- VEGF antibody treatment in patients with renal cell carcinoma (RCC).
A few clinical case reports indicated sunitinib is effective in treating recurrent ovarian
clear cell adenocarcinoma (OCCA) which is almost resistant to second line chemotherapy.
So we would like to conduct this Phase II Sunitinib clinical trial in recurrent / persistent
ovarian clear cell cancer patients.