Brief Title
Biomarkers in Predicting Response in Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Treated on GOG-0172 or GOG-0182
Official Title
ERCC1 Expression as a Predictor of Progression Free and Overall Survival in Patients With Epithelial Ovarian Cancer Treated on GOG Protocols 0172 and 0182
Brief Summary
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the
laboratory may help doctors learn more about changes that occur in DNA and identify
biomarkers related to cancer. It may also help doctors predict how well patients will respond
to treatment.
PURPOSE: This research study is looking at biomarkers in predicting response in patients with
advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Detailed Description
OBJECTIVES:
Primary
- To evaluate ERCC1 tumor expression, as measured by IHC, as a predictor of
progression-free and overall survival of patients with advanced ovarian epithelial
cancer.
Secondary
- To correlate ERCC1 single-nucleotide polymorphisms (C8092A and codon 118) with ERCC1
tumor expression.
OUTLINE: This is a multicenter study.
Blood and paraffin-embedded tumor tissue samples are analyzed for ERCC1 tumor expression by
IHC and single-nucleotide polymorphisms.
Study Type
Observational
Primary Outcome
Association between ERCC1 tumor expression and progression-free and overall survival
Secondary Outcome
Association between ERCC1 polymorphisms and ERCC1 tumor expression
Condition
Fallopian Tube Cancer
Intervention
gene expression analysis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Genetic
Estimated Enrollment
513
Start Date
February 2010
Primary Completion Date
March 2010
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced invasive ovarian epithelial carcinoma, fallopian
tube adenocarcinoma, or primary peritoneal carcinoma
- Has undergone optimal surgical staging
- Has received chemotherapy on either GOG-0172 or GOG-0182
- Adequate blood or DNA available for ERCC1 analysis
- Adequate tumor on paraffin-embedded tissue for IHC staining
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Thomas C. Krivak, MD, ,
Administrative Informations
NCT ID
NCT01074398
Organization ID
CDR0000663840
Secondary IDs
GOG-8012
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Thomas C. Krivak, MD, Study Chair, University of Pittsburgh
Verification Date
February 2010