YKL-40 in Serum Samples From Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy

PRIMARY OBJECTIVES:

I. To assess the ability of the YKL-40 serum marker to detect response or lack of response to
primary chemotherapy in International Federation of Gynecology and Obstetrics (FIGO) stage
III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer.

II. To compare the predictive accuracy of YKL-40 with cancer antigen 125 (CA125).

SECONDARY OBJECTIVES:

I. To test the ability of the YKL-40 serum marker to detect recurrence of ovarian, primary
peritoneal, or fallopian tube cancer in patients who are in first remission following primary
chemotherapy.

II. To test the ability of the YKL-40 serum marker to predict poor risk patients with FIGO
stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer.

TERTIARY OBJECTIVES:

I. To explore alternative cut-off values for YKL-40 elevation in this large patient
population.

II. To describe the variability of YKL-40 and CA125 measurements in patients receiving
primary chemotherapy and in primary remission in a large patient population.

III. To describe the accuracy of YKL-40 coupled with CA125 measurements in predicting
chemotherapy response, progression-free survival and overall survival.

OUTLINE:

Patients undergo collection of serum samples for analysis of YKL-40 via enzyme-linked
immunosorbent assay (ELISA) and CA125 via chemiluminometric sandwich immunoassay at the
following time-points: at baseline; prior to beginning each course of chemotherapy (courses
1-6); at completion of chemotherapy; every 3 months during years 1-2 post-chemotherapy; every
6 months during years 3-5 post-chemotherapy; every year during years 6-10 post-chemotherapy;
and at time of disease recurrence or progression.

Inclusion Criteria:

- Patients with a histologic diagnosis of FIGO stage III or IV invasive epithelial
ovarian, primary peritoneal, or fallopian tube carcinoma who will receive primary
chemotherapy for newly diagnosed disease; eligible histologic cell types include
serous, mucinous, endometrioid, clear cell, transitional, mixed epithelial,
undifferentiated, adenocarcinoma, not otherwise specified (NOS) and malignant Brenner
tumor

- Patients who have undergone full surgical staging as described in the Gynecologic
Oncology Group (GOG) Surgical Procedures Manual

- Patients who have met the pre-entry requirements

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information

Exclusion Criteria:

- The following histologic cell types are not eligible: carcinosarcoma (malignant mixed
Mullerian tumor) and borderline epithelial tumors (low malignant potential, atypical
proliferative)

- Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly
"tumors of low malignant potential") or recurrent invasive epithelial ovarian cancer
treated with surgery only (such as those with stage IA or IB low grade lesions) are
not eligible; patients with a prior diagnosis of a borderline tumor that was
surgically resected and who subsequently develop an unrelated, new invasive epithelial
ovarian or peritoneal primary cancer are eligible, provided that they have not
received prior chemotherapy for any ovarian tumor

- Patients who have received prior chemotherapy for any abdominal or pelvic tumor are
excluded; patients may have received prior adjuvant chemotherapy for localized breast
cancer, provided that it was completed more than three years prior to registration,
and that the patient remains free of recurrent or metastatic disease

- Patients with synchronous primary endometrial cancer, or a past history of primary
endometrial cancer, are excluded, unless all of the following conditions are met:
stage not greater than IB; no more than superficial myometrial invasion, without
vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary
serous, clear cell or other FIGO grade 3 lesions

- With the exception of non-melanoma skin cancer and other specific malignancies as
noted above, patients with other invasive malignancies who had (or have) any evidence
of the other cancer present within the last five years or whose previous cancer
treatment contraindicates this protocol therapy are excluded

- Patients who receive neoadjuvant chemotherapy prior to surgical staging

- Individuals with a diagnosis of rheumatoid arthritis, severe uncontrolled
osteoarthritis, hepatic fibrosis or other active chronic inflammatory condition