A Prospective Trial of COXEN Chemotherapy Prediction

NCT ID: NCT01228942

Last Updated: 2014-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-06-30

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.

Conditions

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Ovarian Neoplasms Fallopian Tube Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

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Platinum Sensitive

Treatment with platinum-based therapy; COXEN prediction model chooses secondary agent if doublet

Group Type OTHER

COXEN analysis for chemotherapy prediction

Intervention Type DEVICE

Using the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined

Platinum resistent

single agent based on Coxen prediction model

Group Type OTHER

COXEN analysis for chemotherapy prediction

Intervention Type DEVICE

Using the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined

Interventions

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COXEN analysis for chemotherapy prediction

Using the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined

Intervention Type DEVICE

Other Intervention Names

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Affymetrix genechip

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Linda R Duska

Medical Attending

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda Duska, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Other Identifiers

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15248

Identifier Type: -

Identifier Source: org_study_id

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