A Prospective Trial of COXEN Chemotherapy Prediction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ovarian Neoplasms, Fallopian Tube Neoplasms

Intervention / Treatment
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* Device: COXEN analysis for chemotherapy prediction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | 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 | patient will be tracked for life | subject lifetime | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer, fallopian tube cancer, primary peritoneal cancer