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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01228942
Other study ID # 15248
Secondary ID
Status Withdrawn
Phase N/A
First received October 20, 2010
Last updated June 5, 2014
Start date October 2010
Est. completion date June 2013

Study information

Verified date June 2014
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2013
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 95 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
COXEN analysis for chemotherapy prediction
Using the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Outcome

Type Measure Description Time frame Safety issue
Primary overall response rate patient will have CT scans and CA 125 drawn to track response to chemotherapy 12 months No
Secondary overall survival patient will be tracked for life subject lifetime No
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