A Prospective Trial of COXEN Chemotherapy Prediction

June 5, 2014 updated by: Linda R Duska, University of Virginia

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Platinum Sensitive
Treatment with platinum-based therapy; COXEN prediction model chooses secondary agent if doublet
Device: COXEN analysis for chemotherapy prediction
Using the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined
Other Names:
  • Affymetrix genechip
Other: Platinum resistent
single agent based on Coxen prediction model
Device: COXEN analysis for chemotherapy prediction
Using the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined
Other Names:
  • Affymetrix genechip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: 12 months
patient will have CT scans and CA 125 drawn to track response to chemotherapy
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: subject lifetime
patient will be tracked for life
subject lifetime

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Linda Duska, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 27, 2010

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15248

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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