Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Research Study in Patients with Advanced Epithelial Ovarian Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Biomarker/Laboratory analysis Approved-not yet active Any age NCI GOG-8004

Objectives

1. Utilize array comparative genomic hybridization and Taqman analyses, a quantitative genomic polymerase chain reaction, to validate the observation that a gain in chromosome 8q is predictive of shorter progression-free survival in patients with primary grade 2 or grade 3 advanced serous papillary ovarian cancer.
2. Utilize these analyses to determine whether a gain in chromosome 8q is predictive of worse overall survival in these patients.
3. Utilize these analyses to determine whether other previously identified chromosomal changes (3q gain, 7q gain, 16q loss, and 17pter-q21 loss) predict outcome in these patients and the association between these changes and clinical characteristics.
4. Utilize these analyses to identify up to 5 additional chromosomal changes and their association that may predict outcome (progression-free and overall survival) in these patients.

Entry Criteria

Disease Characteristics:

• Stage III or IV, high-grade (grade 2 or 3) ovarian cancers
  • No borderline or low-grade (grade 1) tumors
  • Tissue from predominately serous ovarian cancer only
    • No clear cell, endometrioid, mucinous, transitional cell, or mixed without predominant serous component



• Tissue obtained during prior optimal or suboptimal cytoreductive surgery



• Must be enrolled on GOG-0136 and a GOG front-line paclitaxel/platinum chemotherapy trial



• Frozen tissue and hematoxylin-eosin stained section from the ovary obtained at initial surgery

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• Any age

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Expected Enrollment

A total of 158 patient samples will be collected for this study.

Outline

Genomic DNA is isolated from OCT-embedded tissue and analyzed using comparative genomic hybridization. The chromosomal changes identified by this method are compared to those identified using the Taqman method, a quantitative genomic polymerase chain reaction analysis. Chromosome 8q is of specific interest. Other chromosomal changes may be detected in chromosomes 3q, 7q, 16q, and/or 17pter-q21.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

David Gershenson, MD, Protocol chair		Ph: 713-745-2565; 800-392-1611

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