Stage IV Ovarian Cancer Clinical Trial
Official title:
A Prospective, Longitudinal Study of YKL-40 in Patients With FIGO Stage III or IV Invasive Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer Undergoing Primary Chemotherapy
NCT number | NCT00899093 |
Other study ID # | GOG-0235 |
Secondary ID | NCI-2009-01083CD |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | September 2007 |
Verified date | May 2018 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
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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