A Prospective Trial of COXEN Chemotherapy Prediction

Ovarian Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01228942
• Other study ID #: 15248
• Status: Withdrawn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• Status: Withdrawn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

• Fallopian Tube Neoplasms
• Neoplasms
• Ovarian Neoplasms

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