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临床试验/NCT01228942
NCT01228942撤回不适用

A Prospective Trial of COXEN Chemotherapy Prediction in Persistent and Recurrent Ovarian, Fallopian Tube, and Peritoneal Carcinomas

University of Virginia0 个研究点开始时间: 2010年10月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda R Duska

Medical Attending

University of Virginia

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