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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platinum Sensitive | Other | Treatment with platinum-based therapy; COXEN prediction model chooses secondary agent if doublet |
|
| Platinum resistent | Other | single agent based on Coxen prediction model |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COXEN analysis for chemotherapy prediction | Device | Using the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | patient will have CT scans and CA 125 drawn to track response to chemotherapy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | patient will be tracked for life | subject lifetime |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Duska, MD | University of Virginia | Principal Investigator |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |