A Prospective Trial of COXEN Chemotherapy Prediction in Persistent and Recurrent Ovarian, Fallopian Tube, and Peritoneal Carcinomas
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- overall response rate
研究概览
简要总结
The purpose of this study is to determine if the COXEN algorithm, using the diagnostic device Affymetrix GeneChip, is able to predict which chemotherapies will be best for treatment of recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.
详细描述
The current proposal seeks to apply and extend this novel genomic prediction technique to finding better chemotherapeutic options for recurrent ovarian cancer using individual patients' gene-expression signatures of chemosensitivity. The utility of the COXEN technique has been validated and found to accurately predict 1) the chemosensitivity of an independent panel of 40 bladder cancer cell lines; 2) activity of each of the >45K candidate compounds in the NCI-60 drug screening database, which resulted in the identification of a highly-effective novel compound for bladder cancer and patients' responses and survival on 12 historical clinical trials of combination chemotherapy. In particular, the GEMs of breast cancer can be used to stratify both clinical response and overall patient survival with a striking difference between the predicted responders vs. predicted non-responders in 5 independent chemotherapeutic trials of breast cancer. The next step is to test the prediction model in recurrent ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age greater than 18
- •diagnosis of recurrent, persistent, refractory ovarian, fallopian or primary peritoneal cancer
- •tumor tissue, ascites or pleural fluid available for biopsy
- •life expectancy greater than 6 months
排除标准
- •patients with borderline or low malignant histologies
- •patients with a history of other malignancies within last 5 years
结局指标
主要结局
overall response rate
时间窗: 12 months
patient will have CT scans and CA 125 drawn to track response to chemotherapy
次要结局
- overall survival(subject lifetime)
研究者
Linda R Duska
Medical Attending
University of Virginia
