Official Title
Topoisomerase 2-Alpha (TOPO2A) Genomic Alterations and Immunohistochemical Expression as Well as Chromosome 17 Polysomy in Advanced or Recurrent Endometrial Carcinoma Treated With Anthracycline-Based Therapy
Brief Title
Biomarkers in Tumor Tissue Samples From Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Protocol ID
NCT01164735
Lead Sponsor
Gynecologic Oncology Group
Brief Summary
This research study is studying biomarkers in tissue samples from patients with stage
III, stage IV, or recurrent endometrial cancer. Studying samples of tumor tissue from
patients with cancer in the laboratory may help doctors learn more about changes that
occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the frequency of topoisomerase 2-alpha (TOPO2A) gene copy number
alterations (including deletions, gains, and amplification), immunohistochemical
expression, and chromosome 17 polysomy in tumor tissue samples from patients with
advanced or recurrent endometrial carcinoma treated with anthracycline-based therapy on
Gynecologic Oncology Group (GOG)-0177.
II. To assess the relationship between TOPO2A gene copy number alterations, TOPO2A
protein expression, chromosome 17 polysomy, and human epidermal growth factor receptor 2
(HER2) status in tumor tissue samples from these patients.
III. To assess the association between TOPO2A status (TOPO2A gene copy number alterations
and TOPO2A protein expression), or chromosome 17 polysomy and clinical covariates (e.g.,
age, race/ethnicity, cell type, histologic grade, disease stage, regimen type).
IV. To assess the association between TOPO2A status or chromosome 17 polysomy with
measures of clinical outcome including response, progression-free survival, and overall
survival of patients treated with this regimen.
V. To evaluate the potential identification of cut points for TOPO2A protein expression
with potential prognostic value in patients treated with this regimen.
OUTLINE:
Archived tumor tissue samples are analyzed for topoisomerase 2-alpha gene alteration and
expression and chromosome 17 polysomy by fluorescent in situ hybridization (FISH) and
immunohistochemistry (IHC). Clinical information associated with each endometrial
carcinoma sample (e.g., age, race/ethnicity, cell type, histologic grade, disease stage,
and regimen type) is also collected.
Enrollment Count
169 participants
Eligibility Criteria
Inclusion Criteria:
- Chemotherapy-naïve women with histologically documented measurable Stage III, Stage
IV or recurrent endometrial carcinoma with known HER2 status who participated in
Gynecologic Oncology Group (GOG)-0177 are eligible
- Patients must have given permission for their archival formalin-fixed,
paraffin-embedded primary, metastatic or recurrent tumor to be submitted and used
for GOG-0177, and at least one to three unstained slides must be available for FISH
analysis of TOPO2A and CEP17 and immunohistochemical staining for TOPO2A
Exclusion Criteria:
- Women who were not eligible or evaluable on GOG-0177
- Patients who do not have at least one unstained slide archival formalin-fixed,
paraffin-embedded primary, metastatic or recurrent tumor available for fluorescence
in situ hybridization (FISH) analysis of TOPO2A and CEP17 or immunohistochemical
expression of TOPO2A
Filters
Recurrent Uterine Corpus Carcinoma
Stage III Uterine Corpus Cancer
Stage IV Uterine Corpus Cancer
COMPLETED
ADULT
OLDER_ADULT