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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

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ClinicalTrials.gov Identifier: NCT01074398
Recruitment Status : Unknown
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
First Posted : February 24, 2010
Last Update Posted : February 24, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date February 23, 2010
First Posted Date February 24, 2010
Last Update Posted Date February 24, 2010
Study Start Date February 2010
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 23, 2010)		 Association between ERCC1 tumor expression and progression-free and overall survival
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 23, 2010)		 Association between ERCC1 polymorphisms and ERCC1 tumor expression
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
Intervention
  • Genetic: gene expression analysis
  • Genetic: polymorphism analysis
  • Genetic: protein expression analysis
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
Study Groups/Cohorts Not Provided
Publications * Rose PG, Java JJ, Salani R, Geller MA, Secord AA, Tewari KS, Bender DP, Mutch DG, Friedlander ML, Van Le L, Method MW, Hamilton CA, Lee RB, Wenham RM, Guntupalli SR, Markman M, Muggia FM, Armstrong DK, Bookman MA, Burger RA, Copeland LJ. Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma. Obstet Gynecol. 2019 Feb;133(2):245-254. doi: 10.1097/AOG.0000000000003086. Erratum in: Obstet Gynecol. 2019 Apr;133(4):830.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 23, 2010)		 513
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01074398
Other Study ID Numbers CDR0000663840
GOG-8012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Philip J. DiSaia, Gynecologic Oncology Group
Study Sponsor Gynecologic Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Thomas C. Krivak, MD University of Pittsburgh
PRS Account National Cancer Institute (NCI)
Verification Date February 2010