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.

Further Study Details: 

Expected Total Enrollment:  400

Over 80% of advanced stage epithelial cancer patients relapse after attaining first clinical remission with standard platinum/taxane-based chemotherapy. Surrogate biomarkers are needed for predictors of persistent disease and relapse. CA-125, the only FDA-approved ovarian cancer relapse marker, will become elevated in some but not all of the approximately 80 percent of advanced stage 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. We have demonstrated identification of a protein signature pattern that sensitively and specifically recognizes the presence of ovarian cancer (Stages I-IV) in serum from affected women. Furthermore, the pattern can discriminate between affected women and unaffected women and those with the presence of non-malignant gynecologic pathology. We hypothesize that robust changes in proteomic signature patterns will be defined and that these will be reliably predictive of relapse. Further, we hypothesize that the protein signature pattern changes will be as good as or better than CA-125 as a single marker alone or in combination with CA-125 monitoring.

Genders Eligible for Study:  Female

Criteria

INCLUSION CRITERIA:
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.
Pathology of the primary tumor must be confirmed by the registering center prior to protocol entry.
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 platinum/taxane-containing chemotherapy of no more than 8 total cycles.
Patients who elect to undergo second look laparotomy or laparoscopy will be eligible to enroll. Those who have microscopic evidence of residual disease are eligible to enroll if the therapeutic plan is observation. The research blood samples will be censored from use in the training set, but will be available for use in the validation set. If a patient underwent a second look procedure, this will be so noted on the Case Report On Study Form and a copy of the pathology report will be obtained for the master file.
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).
Patients must be able and willing to provide informed consent to participate in the trial.
Patients must have laboratory evidence of good end organ function by criteria below. The upper limit of normal is based upon each registering center's laboratory normal ranges.
Total bilirubin less than or equal to 1.5;
AST (SGOT) and ALT (SGPT) less than or equal to 1.5 x institutional upper limit of normal;
Creatinine or creatinine clearance less than or equal to 1.5; greater than or equal to 45 mL/min/1.73m(2) for patients with creatinine levels above institutional normal;
Activated partial thromboplastin time (PTT) less than 1.25 x institutional upper limits of normal;
Prothrombin Time (PT) or INR less than 1.25 x institutional upper limits of normal.
EXCLUSION CRITERIA:
Patients with nonepithelial ovarian cancer, mixed epithelial/nonepithelial ovarian cancer, or tumors of low malignant potential. Patients with stage I or II epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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.
Patients with a life expectancy of less than 6 months for any reason.
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.

Maryland
      National Cancer Institute (NCI), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  040232; 04-C-0232
Record last reviewed:  June 14, 2004
Last Updated:  November 23, 2004
Record first received:  July 2, 2004
ClinicalTrials.gov Identifier:  NCT00086567
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08