NCT01228942

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

2 years

First QC Date

October 20, 2010

Last Update Submit

June 5, 2014

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Keywords

ovarian cancerfallopian tube cancerprimary peritoneal cancer

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    patient will have CT scans and CA 125 drawn to track response to chemotherapy

    12 months

Secondary Outcomes (1)

  • overall survival

    subject lifetime

Study Arms (2)

Platinum Sensitive

OTHER

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

Device: COXEN analysis for chemotherapy prediction

Platinum resistent

OTHER

single agent based on Coxen prediction model

Device: COXEN analysis for chemotherapy prediction

Interventions

COXEN analysis for chemotherapy predictionDEVICE

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

Also known as: Affymetrix genechip
Platinum SensitivePlatinum resistent

Eligibility Criteria

Age18 Years - 95 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients with borderline or low malignant histologies
  • patients with a history of other malignancies within last 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Linda Duska, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Attending

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 27, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

June 1, 2013

Last Updated

June 6, 2014

Record last verified: 2014-06