Fallopian Tube Neoplasms, Ovarian Neoplasms
Conditions
Keywords
ovarian cancer, fallopian tube cancer, primary peritoneal cancer
Brief summary
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
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.
Interventions
DEVICECOXEN analysis for chemotherapy prediction
Using the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined
Sponsors
University of Virginia
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | 12 months | patient will have CT scans and CA 125 drawn to track response to chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | subject lifetime | patient will be tracked for life |
Outcome results
None listed