Ovarian Neoplasms Clinical Trial
Official title:
A Prospective Trial of COXEN Chemotherapy Prediction in Persistent and Recurrent Ovarian, Fallopian Tube, and Peritoneal Carcinomas
Verified date | June 2014 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 95 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall response rate | patient will have CT scans and CA 125 drawn to track response to chemotherapy | 12 months | No |
Secondary | overall survival | patient will be tracked for life | subject lifetime | No |
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