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

Gynecologic Oncology Group (GOG)

Status: Terminated

Conditions: Stage IV Primary Peritoneal Cancer; Malignant Ovarian Clear Cell Tumor; Stage IIIA Fallopian Tube Cancer; Stage IV Fallopian Tube Cancer; Primary Peritoneal Serous Adenocarcinoma; Undifferentiated Fallopian Tube Carcinoma; Fallopian Tube Clear Cell Adenocarcinoma; Stage IIIC Primary Peritoneal Cancer; Ovarian Adenocarcinoma; Malignant Ovarian Mucinous Tumor; Malignant Ovarian Neoplasm; Undifferentiated Ovarian Carcinoma; Stage IV Ovarian Cancer; Stage IIIB Ovarian Cancer; Fallopian Tube Serous Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; Stage IIIB Primary Peritoneal Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Fallopian Tube Adenocarcinoma; Malignant Ovarian Endometrioid Tumor; Stage IIIB Fallopian Tube Cancer; Malignant Ovarian Serous Tumor; Malignant Ovarian Brenner Tumor; Fallopian Tube Mucinous Adenocarcinoma; Malignant Ovarian Transitional Cell Tumor; Stage IIIA Ovarian Cancer; Malignant Ovarian Mixed Epithelial Tumor; Fallopian Tube Transitional Cell Carcinoma; Stage IIIC Ovarian Cancer

Treatments: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00899093

U10CA027469 (U.S. NIH Grant/Contract)

U10CA180868 (U.S. NIH Grant/Contract)

NCI-2009-01083 (Registry Identifier)

CDR0000540250

GOG-0235 (Other Identifier)

Details and patient eligibility

About

This research trial studies chitinase 3-like 1 (cartilage glycoprotein-39) (YKL-40) in serum samples from patients with newly diagnosed stage III-IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer receiving chemotherapy. Studying samples of serum in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how well patients respond to treatment.

Full description

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.

Enrollment: 2,500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,500 participants in 1 patient group

Ancillary-Correlative (serum collection for YKL-40 and CA125)

Description:

Patients undergo collection of serum samples for analysis of YKL-40 via 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.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Cytology Specimen Collection Procedure