A Prospective Trial of COXEN Chemotherapy Prediction

Not Applicable

Withdrawn

• Conditions: Ovarian Neoplasms; Fallopian Tube Neoplasms
• Interventions: Device: COXEN analysis for chemotherapy prediction

• Registration Number: NCT01228942
• Lead Sponsor: University of Virginia

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 Description

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-27
• Primary Completion: 2012-10
• Study Completion: 2013-06
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-05
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• patients with borderline or low malignant histologies
• patients with a history of other malignancies within last 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Platinum Sensitive	COXEN analysis for chemotherapy prediction	Treatment with platinum-based therapy; COXEN prediction model chooses secondary agent if doublet
Platinum resistent	COXEN analysis for chemotherapy prediction	single agent based on Coxen prediction model

Primary Outcome Measures

Name	Time	Method
overall response rate	12 months	patient will have CT scans and CA 125 drawn to track response to chemotherapy

Secondary Outcome Measures

Name	Time	Method
overall survival	subject lifetime	patient will be tracked for life