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

Brief Title

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

Official Title

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

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 living cells. The test will identify certain proteins that might represent a
      pattern, or "fingerprint," indicating increased risk of disease relapse.

      Women with Stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian
      tube cancer that is in remission may be eligible for this study. Candidates are screened with
      a medical history and physical examination, blood tests, review of pathology report from
      surgery, and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the
      abdomen and pelvis (and chest if the cancer spread to the chest).

      Participants have a clinic visit every 3 months for a physical examination (including a
      pelvic examination), blood draw for routine and research tests, and review of how they have
      been feeling. Every 6 months they have CT scans of the abdomen, pelvis, and possibly the
      chest. When a patient has been in remission for 4 years, blood draws are done every 6 months
      and CT scans are done yearly. Patients whose cancer returns (based on a CA-125 blood test, CT
      scans, or physical examination) end their participation in the study. Patients with an
      abnormal CT scan or physical examination may be asked to undergo a tumor biopsy (surgical
      removal of a piece of tumor tissue) for research purposes.

      ...
    

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 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.
    

Study Type

Observational

Primary Outcome

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

Condition

Fallopian Tube Cancer

Study Arms / Comparison Groups

 patients

Description:  Patients in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Estimated Enrollment

119

Start Date

December 12, 2005

Eligibility Criteria

        -  INCLUSION CRITERIA:

        2.1.1All 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.

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

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

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

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

        2.1.6Histology 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).

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

        2.1.8Patients 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:

        2.2.1Patients 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.

        2.2.2Patients 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.

        2.2.3Patients 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.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Elise C Kohn, M.D., , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00086567

Organization ID

040232

Secondary IDs

04-C-0232

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Elise C Kohn, M.D., Principal Investigator, National Cancer Institute (NCI)

Verification Date

January 24, 2023