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A Prospective Trial of COXEN Chemotherapy Prediction

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University of Virginia

Status

Withdrawn

Conditions

Ovarian Neoplasms
Fallopian Tube Neoplasms

Treatments

Device: COXEN analysis for chemotherapy prediction

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Platinum Sensitive
Other group
Description:
Treatment with platinum-based therapy; COXEN prediction model chooses secondary agent if doublet
Treatment:
Device: COXEN analysis for chemotherapy prediction
Platinum resistent
Other group
Description:
single agent based on Coxen prediction model
Treatment:
Device: COXEN analysis for chemotherapy prediction

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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