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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00899093
Other study ID # GOG-0235
Secondary ID NCI-2009-01083CD
Status Terminated
Phase
First received
Last updated
Start date September 2007

Study information

Verified date May 2018
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2500
Est. completion date
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Brenner Tumor
  • Carcinoma
  • Carcinoma, Endometrioid
  • Carcinoma, Transitional Cell
  • Cystadenocarcinoma
  • Fallopian Tube Adenocarcinoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Mucinous Adenocarcinoma
  • Fallopian Tube Neoplasms
  • Fallopian Tube Serous Adenocarcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Malignant Ovarian Brenner Tumor
  • Malignant Ovarian Clear Cell Tumor
  • Malignant Ovarian Endometrioid Tumor
  • Malignant Ovarian Mixed Epithelial Tumor
  • Malignant Ovarian Mucinous Tumor
  • Malignant Ovarian Neoplasm
  • Malignant Ovarian Serous Tumor
  • Malignant Ovarian Transitional Cell Tumor
  • Neoplasms
  • Ovarian Adenocarcinoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Primary Peritoneal Serous Adenocarcinoma
  • Stage IIIA Fallopian Tube Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIA Primary Peritoneal Cancer
  • Stage IIIB Fallopian Tube Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIB Primary Peritoneal Cancer
  • Stage IIIC Fallopian Tube Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IIIC Primary Peritoneal Cancer
  • Stage IV Fallopian Tube Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Primary Peritoneal Cancer
  • Undifferentiated Fallopian Tube Carcinoma
  • Undifferentiated Ovarian Carcinoma

Intervention

Other:
Cytology Specimen Collection Procedure
Correlative studies
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States Abington Memorial Hospital Abington Pennsylvania
United States Akron General Medical Center Akron Ohio
United States Summa Akron City Hospital/Cooper Cancer Center Akron Ohio
United States Saint Anthony's Health Alton Illinois
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States AnMed Health Cancer Center Anderson South Carolina
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Northside Hospital Atlanta Georgia
United States Woman's Hospital Baton Rouge Louisiana
United States Billings Clinic Cancer Center Billings Montana
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Island Gynecologic Oncology Brightwaters New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Aultman Health Foundation Canton Ohio
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States Miami Valley Hospital Dayton Ohio
United States Beaumont Hospital-Dearborn Dearborn Michigan
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Saint John Hospital and Medical Center Detroit Michigan
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Sacred Heart Hospital Eau Claire Wisconsin
United States Saint Elizabeth Medical Center South Edgewood Kentucky
United States Union Hospital of Cecil County Elkton Maryland
United States Highlands Oncology Group PA - Fayetteville Fayetteville Arkansas
United States Hurley Medical Center Flint Michigan
United States Baylor All Saints Medical Center at Fort Worth Fort Worth Texas
United States New York Hospital Medical Center of Queens Fresh Meadows New York
United States Genesys Regional Medical Center Grand Blanc Michigan
United States Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Greenville Health System Cancer Institute-Eastside Greenville South Carolina
United States Greenville Health System Cancer Institute-Faris Greenville South Carolina
United States Greenville Memorial Hospital Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Hartford Hospital Hartford Connecticut
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Sudarshan K Sharma MD Limted-Gynecologic Oncology Hinsdale Illinois
United States Franciscan Health Indianapolis Indianapolis Indiana
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Saint Vincent Hospital and Health Care Center Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Providence Medical Center Kansas City Kansas
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Knoxville Gynecologic Cancer Specialists PC Knoxville Tennessee
United States Sparrow Hospital Lansing Michigan
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Beebe Medical Center Lewes Delaware
United States Baptist Health Lexington Lexington Kentucky
United States Saint Mary Mercy Hospital Livonia Michigan
United States Central Georgia Gynecologic Oncology Macon Georgia
United States Marshfield Clinic Marshfield Wisconsin
United States Saint Joseph's Hospital Marshfield Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin
United States Winthrop University Hospital Mineola New York
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States University of South Alabama Mitchell Cancer Institute Mobile Alabama
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Mercy Health Partners-Hackley Campus Muskegon Michigan
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States The Hospital of Central Connecticut New Britain Connecticut
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States UF Cancer Center at Orlando Health Orlando Florida
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Saint Joseph's Hospital and Medical Center Phoenix Arizona
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Maine Medical Center-Bramhall Campus Portland Maine
United States Women and Infants Hospital Providence Rhode Island
United States Black Hills Obstetrics and Gynecology Rapid City South Dakota
United States Marshfield Clinic at James Beck Cancer Center Rhinelander Wisconsin
United States Marshfield Clinic-Rice Lake Center Rice Lake Wisconsin
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Rutherford Hospital Rutherfordton North Carolina
United States Saint Mary's of Michigan Saginaw Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Saint Louis-Cape Girardeau CCOP Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Greenville Health System Cancer Institute-Seneca Seneca South Carolina
United States Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina
United States Spartanburg Medical Center Spartanburg South Carolina
United States Baystate Medical Center Springfield Massachusetts
United States Cancer Research for the Ozarks NCORP Springfield Missouri
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point Wisconsin
United States Saint Michael's Hospital Stevens Point Wisconsin
United States Stony Brook University Medical Center Stony Brook New York
United States State University of New York Upstate Medical University Syracuse New York
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Carle Cancer Center Urbana Illinois
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Reading Hospital West Reading Pennsylvania
United States Diagnostic and Treatment Center Weston Wisconsin
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina
United States Southeast Clinical Oncology Research (SCOR) Consortium NCORP Winston-Salem North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States University of Massachusetts Memorial Health Care Worcester Massachusetts
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Main Line Health NCORP Wynnewood Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Chemotherapy response As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting chemotherapy response will be described. Up to 10 years
Other Optimal cut-off values for YKL-40 Optimal cut-off values for YKL-40 that subsequently can be used in clinical practice will be determined. Any statistical significance calculated for an optimized cut-off will adjust for the selection process, and any comparison with CA-125 will treat both markers in the same way. Up to 10 years
Other Overall survival As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting overall survival will be described. From entry into the study to death or the date of last contact, assessed up to 10 years
Other Progression-free survival As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting progression-free survival will be described. From study entry until disease progression, death or date of last contact, assessed up to 10 years
Other Variability of CA125 measurements Linear statistical methods, such as a random effects model, will be used to assess the variability and correlation of CA125 over time in this population. Up to 10 years
Other Variability of YKL-40 measurements Linear statistical methods, such as a random effects model, will be used to assess the variability and correlation of YKL-40 over time in this population. Up to 10 years
Primary CA125 measurements The accuracy of each marker alone will be compared using area under the ROC curve, and assess which adds more predictive information when both are included in logistic regression. Up to 10 years
Primary Objective response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria In order to make a valid comparison between CA125 and YKL-40, in this study computed tomography (CT) criteria will be treated as the "gold standard" and whether changes in YKL-40 levels correlate with CT evidence as well as or better than changes in CA125 levels will be evaluated. Up to 10 years
Primary Time to disease progression using RECIST criteria Parallel statistical analyses of time to disease progression will also be conducted for patients who do not respond. Up to 10 years
Primary Time to tumor recurrence (relapse) Parallel analyses of the markers as predictors of time-to-relapse will be performed using survival-type regression methods such as the Cox proportional hazards model or a parametric maximum likelihood model. The total number of patients available for analysis of time to relapse is the number of patients who respond to treatment. From study entry until disease recurrence, death or date of last contact, assessed up to 10 years
Primary YKL-40 measurements YKL-40 will be compared to CA125 in terms of its ability to detect response to chemotherapy (during chemotherapy) and recurrence of disease (in remission). Serum YKL-40 behavior will also be assessed as a reflection of tumor histology, tumor grade, and tumor stage—all in comparison to CA125. The accuracy of each marker alone will be compared using area under the receiver operating characteristic (ROC) curve, and assess which adds more predictive information when both are included in logistic regression. Up to 10 years
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