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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00086567
First received: July 2, 2004
Last updated: November 11, 2014
Last verified: June 2014
  Purpose

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.


Condition
Ovarian Neoplasms
Fallopian Tube Neoplasms
Genital Neoplasms, Female

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 8
Study Start Date: June 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

2.1.1< 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.

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

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

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

2.1.5< 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.

2.1.6< 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).

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

2.1.8< 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:

2.2.1< 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.

2.2.2< 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.

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

2.2.4 < 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.

2.2.5 < 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086567

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048-1804
United States, Illinois
Evanston Northwestern University Hospital
Evanston, Illinois, United States
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington/Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 28104
Sponsors and Collaborators
Investigators
Principal Investigator: Elise C Kohn, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT00086567     History of Changes
Obsolete Identifiers: NCT00119353
Other Study ID Numbers: 040232, 04-C-0232
Study First Received: July 2, 2004
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Blood
Testing
Gynecologic
Fallopian
Peritoneal
Epithelial Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Genital Neoplasms, Female
Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014