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A Pilot Study of Proteomic Evaluation of Epithelial Ovarian Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile Associated With Relapse


N/A
N/A
N/A
Not Enrolling
Both
Ovarian Neoplasm

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Trial Information

A Pilot Study of Proteomic Evaluation of Epithelial Ovarian Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile Associated With Relapse


Over 80 percent of advanced stage epithelial cancer patients relapse after attaining first
clinical remission with standard platinum/paclitaxel-based chemotherapy. Surrogate
biomarkers are needed for the evaluation of efficacy of treatment and for use as predictors
of disease in screening and for relapse diagnosis. CA-125, the existing ovarian cancer
marker, will become elevated with relapse in some but not all of the 80 percent of patients
for whom it was increased at initial diagnosis. Elevation in CA-125 may precede clinical
evidence of relapse by as much as 6 - 10 months or lag behind clinical relapse by the same
time intervals, making it a less than satisfactory clinical tool. Emerging proteomic
technologies allow for scanning of cellular proteins in a simple, short, reproducible, and
quantitative chemical assay. We hypothesize that changes in a patient's protein pattern will
be detectable and will be reliably associated with relapse. This protocol is a pilot study
for our ability to ascertain and evaluate samples from ovarian cancer patients followed in
first clinical remission, and investigate whether analysis of sequential protein
fingerprints will yield a reproducible pattern of change that may be associated with
relapse.

Inclusion Criteria


- INCLUSION CRITERIA

All patients in first clinical remission from treatment of FIGO stage III/IV primary
peritoneal, fallopian tube, or epithelial ovarian carcinoma or stage IIC clear cell
histology epithelial ovarian cancer as defined by: normal CA-125, normal physical exam,
normal post hysterectomy pelvic examination, no evidence of disease on CT scan or other
noninvasive reassessment.

Entry within 9 weeks of completion of final cycle of chemotherapy (within 12 weeks of last
administration of chemotherapy).

S/P completion of primary therapy with standard platinum/paclitaxel or
carboplatin/paclitaxel-containing chemotherapy and in confirmed clinical complete
response.

At least one block from the primary tumor must be received. (If available, a sample of
frozen primary tumor should also be forwarded).

ECOG performance status of 0, 1, or 2.

EXCLUSION CRITERIA

Patients with nonepithelial ovarian cancer, or mixed epithelial/nonepithelial ovarian
cancer.

Patients may not be receiving chemotherapy, hormonal therapy, alternative therapy, or
radiation therapy. No therapy of any kind is allowed while the patient is on-study.
Replacement hormonal therapy is not allowed.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Elise C Kohn, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

000018

NCT ID:

NCT00001938

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Ovarian Neoplasm
  • SELDI
  • Markers
  • Complete Response
  • Screening
  • Ovary
  • Ovarian Cancer
  • Proteomics
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892