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Status:

COMPLETED

Predictors of Relapse of Ovarian, Peritoneal, and Fallopian Tube Cancers

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Fallopian Tube Cancer

Peritoneal Neoplasms

Eligibility:

FEMALE

18+ years

Brief Summary

This study will develop a blood test that can be used to predict a relapse of ovarian, peritoneal, or fallopian tube cancer. The type of testing is called proteomics, or the study of proteins in livin...

Detailed Description

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 satisf...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • 1.1\<TAB\>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.
  • 1.2\<TAB\>Pathology of the primary tumor must be confirmed by the registering center prior to protocol entry.
  • 1.3\<TAB\>Entry within 9 weeks of completion of final cycle of chemotherapy (within 12 weeks of last administration of chemotherapy).
  • 1.4\<TAB\>S/P surgical debulking and completion of primary therapy with platinum/taxane -containing chemotherapy of no more than 8 total cycles.
  • 1.5\<TAB\>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.
  • 1.6\<TAB\>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).
  • 1.7\<TAB\>Patients must be able and willing to provide informed consent to participate in the trial.
  • 1.8\<TAB\>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:
  • 2.1\<TAB\>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\<TAB\>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.
  • 2.3\<TAB\>Patients with a life expectancy of less than 6 months for any reason.
  • 2.4 \<TAB\>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.
  • 2.5 \<TAB\>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.

Exclusion

    Key Trial Info

    Start Date :

    December 12 2005

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    119 Patients enrolled

    Trial Details

    Trial ID

    NCT00086567

    Start Date

    December 12 2005

    Last Update

    January 8 2026

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States

    2

    Cedars Sinai Medical Center

    Los Angeles, California, United States, 90048-1804

    3

    Evanston Northwestern University Hospital

    Evanston, Illinois, United States

    4

    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892