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

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:

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.