Clinical Trial: A Prospective Trial of COXEN Chemotherapy Prediction

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Virginia

Current Primary Outcome: overall response rate [ Time Frame: 12 months ]

patient will have CT scans and CA 125 drawn to track response to chemotherapy


Original Primary Outcome: Same as current

Current Secondary Outcome: overall survival [ Time Frame: subject lifetime ]

patient will be tracked for life


Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: October 20, 2010
Date Started: October 2010
Date Completion:
Last Updated: June 5, 2014
Last Verified: June 2014