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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


OBJECTIVES:

Primary

- Assess the ability of the serum marker, YKL-40, to detect response or lack of response
to primary chemotherapy in patients with newly diagnosed stage III or IV invasive
ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.

- Compare the predictive accuracy of YKL-40 vs CA-125, in terms of disease response to
chemotherapy and relapse, in these patients.

Secondary

- Assess the ability of YKL-40 to detect recurrence of ovarian epithelial, primary
peritoneal cavity, or fallopian tube cancer in patients who are in first remission
after primary chemotherapy.

- Assess the ability of YKL-40 to predict poor outcome in these patients.

- Determine alternative cutoff values for YKL-40 elevation in these patients.

- Determine the variability of YKL-40 and CA-125 measurements in patients receiving
primary chemotherapy and in patients in primary remission.

- Determine the accuracy of YKL-40 coupled with CA-125 measurements in predicting
chemotherapy response, progression-free survival, and overall survival of these
patients.

OUTLINE: This is a prospective, longitudinal study.

Patients undergo blood collection at baseline and then periodically thereafter for
evaluation of tumor marker YKL-40. Serum values for YKL-40 are compared with those of
another tumor marker, CA-125, to assess the sensitivity and specificity of YKL-40 in
detecting early-stage cancer, response to treatment, and disease relapse.

Patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 2,500 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of 1 of the following:

- Invasive ovarian epithelial cancer

- Primary peritoneal cavity cancer

- Fallopian tube cancer

- FIGO stage III or IV disease

- The following histologic cell types are allowed:

- Serous adenocarcinoma

- Mucinous adenocarcinoma

- Endometrioid adenocarcinoma

- Clear cell adenocarcinoma

- Transitional cell carcinoma

- Mixed epithelial carcinoma

- Undifferentiated carcinoma

- Adenocarcinoma not otherwise specified

- Malignant Brenner tumor

- The following histologic cell types are not allowed:

- Carcinosarcoma (i.e., malignant mixed Müllerian tumor)

- Borderline epithelial tumors (i.e., low malignant potential or atypical
proliferative tumors)

- Patients with a prior diagnosis of a borderline tumor that was surgically
resected who subsequently develop an unrelated, new, invasive ovarian
epithelial or peritoneal primary cancer are eligible provided patient
received no prior chemotherapy for any ovarian tumor

- Newly diagnosed disease AND planning to receive primary chemotherapy

- Has undergone full surgical staging

- No recurrent invasive ovarian epithelial cancer treated with surgery only (e.g.,
stage IA or IB low-grade lesions)

- No synchronous primary endometrial cancer or prior endometrial cancer unless all of
the following criteria are met:

- Stage IA or IB disease

- Superficial myometrial invasion without vascular or lymphatic invasion

- No poorly differentiated subtypes (e.g., papillary serous, clear cell, or other
FIGO grade 3 lesions)

PATIENT CHARACTERISTICS:

- No other invasive malignancies within the past 5 years except for nonmelanoma skin
cancer

- No rheumatoid arthritis, severe uncontrolled osteoarthritis, hepatic fibrosis, or
other active chronic inflammatory condition

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND
no recurrent or metastatic disease

- No prior cancer treatment that contraindicates study therapy

- No prior chemotherapy for any abdominal or pelvic tumor

- No neoadjuvant chemotherapy prior to surgical staging

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Objective response as measured by RECIST criteria

Safety Issue:

No

Principal Investigator

Carol Aghajanian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

Unspecified

Study ID:

CDR0000540250

NCT ID:

NCT00899093

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • ovarian mixed epithelial carcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • Brenner tumor
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIIC primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Hurley Medical CenterFlint, Michigan  48503
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - GreenvilleGreenville, South Carolina  29615
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Winthrop University HospitalMineola, New York  11501
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
St. Elizabeth Medical CenterEdgewood, Kentucky  41017
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
University of South Alabama Mitchell Cancer InstituteMobile, Alabama  36604
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Gynecologic Oncology of IndianaIndianapolis, Indiana  46237
Maine Medical Center - Bramhall CampusPortland, Maine  04102
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Billings Clinic - DowntownBillings, Montana  59107-7000
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Center for Cancer Treatment & Prevention at Sacred Heart HospitalEau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Vince Lombardi Cancer Clinic - SheboyganSheboygan, Wisconsin  53081
Marshfield Clinic at Saint Michael's HospitalStevens Point, Wisconsin  54481
Saint Michael's Hospital Cancer CenterStevens Point, Wisconsin  54481
Marshfield Clinic - Wausau CenterWausau, Wisconsin  54401
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Woman's HospitalBaton Rouge, Louisiana  70815
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Rutherford HospitalRutherfordton, North Carolina  28139
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169
Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio  45220
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
AnMed Cancer CenterAnderson, South Carolina  29621
Central Georgia Gynecologic OncologyMacon, Georgia  31201
Gynecologic Oncology of West MichiganGrand Rapids, Michigan  49546
Black Hills Obstetrics & Gynecology LLPRapid City, South Dakota  57701
Aurora Women's Pavilion of West Allis Memorial HospitalWest Allis, Wisconsin  53227
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
Central Dupage Cancer CenterWarrenville, Illinois  60555
All Saints Episcopal Hospital - Fort WorthFort Worth, Texas  76104