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


N/A
18 Years
95 Years
Open (Enrolling)
Female
Ovarian Neoplasms, Fallopian Tube Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall response rate

Outcome Description:

patient will have CT scans and CA 125 drawn to track response to chemotherapy

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Linda Duska, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Institutional Review Board

Study ID:

15248

NCT ID:

NCT01228942

Start Date:

October 2010

Completion Date:

October 2014

Related Keywords:

  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • ovarian cancer
  • fallopian tube cancer
  • primary peritoneal cancer
  • Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms

Name

Location
University of Virginia Charlottesville, Virginia  22908