Ovarian NeoplasmsNCT01228942
A Prospective Trial of COXEN Chemotherapy Prediction
A study testing COXEN analysis for chemotherapy prediction in people with Ovarian Neoplasms and Fallopian Tube Neoplasms, run by University of Virginia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Ovarian Neoplasms, Fallopian Tube Neoplasms
- What is being tested?
- COXEN analysis for chemotherapy prediction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with borderline or low malignant histologies
- patients with a history of other malignancies within last 5 years
About this study
Official title: A Prospective Trial of COXEN Chemotherapy Prediction in Persistent and Recurrent Ovarian, Fallopian Tube, and Peritoneal Carcinomas
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.
Read the 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.
- Conditions
- Ovarian Neoplasms, Fallopian Tube Neoplasms
- Being tested
- COXEN analysis for chemotherapy prediction
- Keywords
- ovarian cancer, fallopian tube cancer, primary peritoneal cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COXEN analysis for chemotherapy predictionDevice
Also called Affymetrix genechip
Using the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined
| Study group | Role | What they receive |
|---|---|---|
| Platinum Sensitive | Other | Treatment with platinum-based therapy; COXEN prediction model chooses secondary agent if doublet Receives: Device: COXEN analysis for chemotherapy prediction |
| Platinum resistent | Other | single agent based on Coxen prediction model Receives: Device: COXEN analysis for chemotherapy prediction |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
patient will have CT scans and CA 125 drawn to track response to chemotherapy
Measured: 12 months
Secondary outcomes (1)
overall survival
patient will be tracked for life
Measured: subject lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
- Study completionJun 2013
Why it stopped: Lack of funding/resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda R Duska, University of Virginia
- Investigators
- Linda Duska, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228942
- Sponsor's protocol ID
- 15248
- Status last verified
- Jun 2014
- First submitted
- 20 Oct 2010
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of COXEN Chemotherapy Prediction in Persistent and Recurrent Ovarian, Fallopian Tube, and Peritoneal Carcinomas
- ClinicalTrials.gov ID
- NCT01228942
- Acronym / sponsor ID
- 15248
- Conditions
- Ovarian Neoplasms, Fallopian Tube Neoplasms
- Keywords
- ovarian cancer, fallopian tube cancer, primary peritoneal cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding/resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platinum Sensitive | Other | Device: COXEN analysis for chemotherapy predictionTreatment with platinum-based therapy; COXEN prediction model chooses secondary agent if doublet |
| Platinum resistent | Other | Device: COXEN analysis for chemotherapy predictionsingle agent based on Coxen prediction model |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- patients with borderline or low malignant histologies
- patients with a history of other malignancies within last 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COXEN analysis for chemotherapy predictionAlso: Affymetrix genechipUsing the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined | Device | Platinum Sensitive, Platinum resistent |
Primary outcome
overall response rate
Time frame: 12 months
patient will have CT scans and CA 125 drawn to track response to chemotherapy
1 secondary outcome
overall survival
Time frame: subject lifetime
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Duska, MD principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
A study testing COXEN analysis for chemotherapy prediction in people with Ovarian Neoplasms and Fallopian Tube Neoplasms, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.