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A Prospective Trial of COXEN Chemotherapy Prediction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Linda R Duska, University of Virginia
ClinicalTrials.gov Identifier:
NCT01228942
First received: October 20, 2010
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Ovarian Neoplasms
Fallopian Tube Neoplasms
 Device: COXEN analysis for chemotherapy prediction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: A Prospective Trial of COXEN Chemotherapy Prediction in Persistent and Recurrent Ovarian, Fallopian Tube, and Peritoneal Carcinomas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • overall response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    patient will have CT scans and CA 125 drawn to track response to chemotherapy


Secondary Outcome Measures:
  • overall survival [ Time Frame: subject lifetime ] [ Designated as safety issue: No ]
    patient will be tracked for life


Estimated Enrollment: 92
Study Start Date: October 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Affymetrix genechip
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 Name: Affymetrix genechip

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228942

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Linda Duska, MD University of Virginia
  More Information

No publications provided

Responsible Party: Linda R Duska, Medical Attending, University of Virginia
ClinicalTrials.gov Identifier: NCT01228942     History of Changes
Other Study ID Numbers: 15248
Study First Received: October 20, 2010
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
ovarian cancer
fallopian tube cancer
primary peritoneal cancer

Additional relevant MeSH terms:
Neoplasms
Fallopian Tube Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
 Adnexal Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 16, 2013