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A Multi-Institutional Study of Proteomic Evaluation of Epithelial Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile of Relapse


N/A
N/A
N/A
Not Enrolling
Female
Ovarian Neoplasms, Fallopian Tube Neoplasms, Genital Neoplasms, Female

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Trial Information

A Multi-Institutional Study of Proteomic Evaluation of Epithelial Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile of Relapse


Background:

Over 80% of patients with advanced stage epithelial ovarian cancer will relapse

Serum biomarkers are needed for predictors of persistent disease and relapse

CA-125 is a less than satisfactory clinical tool for detecting relapse

A serum repository of samples from women with ovarian cancer is needed to develop and
validate the multiple tests being created for ovarian cancer recurrence and screening.

Objectives:

To create a multi-institutional repository from which investigations of serum proteomic
signature profiles of epithelial ovarian cancer and relapse will be developed and validated

To determine the sensitivity and specificity of the proteomic signature profiles for relapse

To compare the accuracy of proteomic evaluation and CA125 in classifying patient disease
progression

To identify the temporal relationship between a rise in CA125 value versus the development
of proteomic signature profiles of relapse.

To detect the impact of study participation on quality of life.

To collect epidemiological data for patients in the target population

Eligibility:

Patients in first remission from treatment of FIGO stage III/IV primary peritoneal,
fallopian tube, or epithelial ovarian carcinoma as defined by normal CA125, no evidence of
disease on abdominopelvic CT scan, and normal post-hysterectomy physical exam.

Entry within 12 weeks of last administration of chemotherapy.

S/P surgical debulking and completion of primary therapy with platinum/taxane-containing
chemotherapy of no more than a total of 8 cycles.

Laboratory evidence of good end organ function.

Design:

Phase of Trial: Biomarker/Laboratory Analysis.

Number of patients to be enrolled: 400

Planned statistical analysis for primary endpoint: Training set to include 100 women, half
of whom are in remission and half of whom have recurrent disease. Validation set will
include 200 women, half of whom are in remission and half of whom have recurrent disease.

Inclusion Criteria


- INCLUSION CRITERIA:

2.1.1 All patients in first complete response from treatment of FIGO stage III/IV primary
peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by: normal CA-125,
normal post-hysterectomy physical exam, no evidence of disease on abdominopelvic CT scan
(or other noninvasive reassessment, e.g. MRI). PET scans are not acceptable for
confirmation of complete response.

2.1.2 Pathology of the primary tumor must be confirmed by the registering center prior to
protocol entry.

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

2.1.4 S/P surgical debulking and completion of primary therapy with platinum/taxane
-containing chemotherapy of no more than 8 total cycles.

2.1.5 Patients who undergo second look laparotomy or laparoscopy and have microscopic
residual disease but who elect not to have treatment will be eligible to enroll.

2.1.6 Histology slides adequate to confirm the pathology and staging must be submitted to
the coordinating center within 3 months of enrollment. (If available, a sample of frozen
primary tumor should also be forwarded).

2.1.7 Patients must be able and willing to provide informed consent to participate in the
trial.

2.1.8 Patients must have laboratory evidence of good end organ function by criteria in
Table 1 below. The upper limit of normal is based upon each registering center's
laboratory normal ranges.

Laboratory based inclusion criteria:

Laboratory Test: AST(SGOT) and ALT(SGPT)

Required value: less than or equal to 2.5 times the institutional upper limit of normal
creatinine

OR

Laboratory Test: Creatinine

Required value: Less than or equal to 2.0

Laboratory Test: Creatinine clearance

Required Value: Greater than or equal to 45 mL/min/1.73 m(2) for patients with creatinine
levels above institutional normal.

EXCLUSION CRITERIA:

2.2.1 Patients with nonepithelial ovarian cancer, mixed epithelial/nonepithelial ovarian
cancer (i.e., Mixed Malignant Mullerian Tumors), or tumors of low malignant potential.
Patients with stage I or II epithelial ovarian, fallopian tube, or primary peritoneal
cancer.

2.2.2 Patients may not be receiving chemotherapy (therapeutic or consolidation),
maintenance, alternative therapy, or radiation therapy. No anti-cancer therapy of any
kind is allowed while the patient is on-study. Replacement hormonal therapy is allowed
but must be clearly indicated on the case report forms submitted. Hormonal anti-cancer
therapies such as tamoxifen and raloxifene will not be permitted while on study.

2.2.3 Patients with a life expectancy of less than 6 months for any reason.

2.2.4 Patients with a history of other invasive malignancies within the past five years
prior to enrollment except for curatively treated carcinoma in situ of the cervix, ductal
or lobular carcinoma in situ of the breast, concomitant stage I endometrial cancer, or
basal or squamous cell skin cancers.

2.2.5 Complementary and alternative agent use is discouraged on this study due to the
possibility that the use of these agents may alter the serum protein pattern. The
Institutional Principal Investigator will have discretion as to whether complementary or
alternative agent usage will prevent eligibility on a case by case basis.

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:

040232

NCT ID:

NCT00086567

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Genital Neoplasms, Female
  • Blood
  • Testing
  • Gynecologic
  • Fallopian
  • Peritoneal
  • Epithelial Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Neoplasms
  • Fallopian Tube Neoplasms
  • Genital Neoplasms, Female
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892
Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Duke UniversityDurham, North Carolina  27710
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
New York University School of MedicineNew York, New York  10016
Evanston Northwestern University HospitalEvanston, Illinois  
University of Washington/Fred Hutchinson Cancer Research CenterSeattle, Washington  28104