Clinical Trial: Sunitinib® in Patients With Recurrent Ovarian Clear Cell Carcinoma
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
Detailed Summary:
Ovarian cancer is the 10th leading cancer in women in Taiwan. There were 894 new cases in 2004 and 297 women died of ovarian cancer in 2001 according to the data released by the Department of Health. The incidence of epithelial ovarian cancer increases with age and the median age at the time of diagnosis is 63 years, and 70% of patients present with advanced disease.
Primary treatment for ovarian cancer consists of appropriate surgical staging and cytoreductive surgery, followed in most patients by systemic chemotherapy. Initial surgery should be a comprehensive staging laparotomy. For patients with clinical stage III or IV disease, the usual recommendation continues to be maximally cytoreductive surgery followed by adjuvant chemotherapy.
Most patients with epithelial ovarian cancer will receive postoperative systemic chemotherapy. Observation is recommended for stage Ia, grade 1 tumors, owing to their high cure rate. For patients with higher-grade and/or higher-stage tumors, systemic chemotherapy is indicated. The recommendation for specific primary chemotherapy/primary adjuvant therapy is Paclitaxel plus platinum regimens. Paclitaxel plus cisplatin or carboplatin are the recommended regimens. The extent of treatment varies with stage of disease. For patients with advanced-stage disease, six cycles of chemotherapy are recommended, whereas for earlier-stage disease, three to six cycles are recommended, pending the results of ongoing studies in this group of patients.
Treatment of relapsed ovarian cancer Despite the high objective response rate associated with primary platinum/taxane-based chemotherapy in advanced ovarian cancer, the majority of patients will eventually experience disease recurrence and be potential candidates for a second-line treatment approach. Treatment
Sponsor: Cathay General Hospital
Current Primary Outcome: Response rate [ Time Frame: 4 weeks after completion of treatment ]
The tumor response will be assessed according to World Health Organization (WHO) response criteria or Rustin's criteria:
Complete response (CR) Complete disappearance of all clinically detectable lesions for a minimum of 4 weeks. Clinical condition and performance status remains stable or improve.
Partial response (PR) 50% or more decrease in the sum of the products of perpendicular diameters of all measurable lesions or tumor marker-CA125 for a minimum of 4 weeks. Clinical condition and performance status remains stable or improve.
Stable disease (SD) A decrease of less than 50% or an increase of less than 25% of the sum of the products of perpendicular diameters of all measurable lesions or tumor marker CA125 with no development of new lesions for at least 4 weeks.
Progressive disease (PD) Occurrence of new lesions; an increase of 25% or more in the sum of the areas of original measurement, or an elevated 25% of tumor marker CA125.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome: Adverse effect [ Time Frame: every 3 months after initiation of treatment up to 12 months after completion of treatment ]
Information By: Cathay General Hospital
Dates:
Date Received: March 19, 2013
Date Started: January 2013
Date Completion: January 2016
Last Updated: April 7, 2013
Last Verified: April 2013
