Methotrexate or Dactinomycin in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01535053
First received: February 14, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.


Condition Intervention Phase
Gestational Trophoblastic Tumor
Hydatidiform Mole
Low Risk Metastatic Gestational Trophoblastic Tumor
Uterine Choriocarcinoma
Drug: leucovorin calcium
Biological: dactinomycin
Drug: methotrexate
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-Day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Complete response vs treatment failure [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Overall QOL [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
    The FACT-G scale will be used to measure the overall QOL and is considered the primary QOL endpoint.


Estimated Enrollment: 384
Study Start Date: June 2012
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (leucovorin calcium and methotrexate)
Patients receive methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single-agent methotrexate IV on days 1-5.
Drug: leucovorin calcium
Given PO
Other Names:
  • CF
  • CFR
  • LV
Drug: methotrexate
Given IV and IM
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Active Comparator: Arm II (dactinomycin)
Patients receive dactinomycin IV over 15 minutes on day 1.
Biological: dactinomycin
Given IV
Other Names:
  • ACT-D
  • actinomycin C1
  • AD
  • Cosmegen
  • DACT
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed Description:

PRIMARY OBJECTIVES:

I. To test the hypothesis that treatment with multi-day methotrexate is inferior to treatment with pulse actinomycin-D (dactinomycin) in patients with low-risk gestational trophoblastic disease with respect to complete response.

SECONDARY OBJECTIVES:

I. To describe the frequency of post protocol surgical treatment for each arm. II. To describe the frequency of post protocol multi-agent chemotherapy treatment for each arm.

III. To compare multi-day methotrexate to actinomycin-D with respect to frequency and severity of adverse events in patients with low-risk gestational trophoblastic neoplasia.

IV. To investigate the impact of treatment on overall quality-of-life (QOL) and explore the influence of treatment on issues such as body image, sexual functioning, and patient-reported side effects and disruption.

V. To assess whether uterine artery pulsatility index (UAPI) can provide independent prognostic information predictive of single-drug resistance.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive methotrexate intramuscularly (IM) on days 1, 3, 5, and 7 and leucovorin calcium orally (PO) on days 2, 4, 6, and 8 OR single-agent methotrexate IV on days 1-5.

ARM II: Patients receive dactinomycin IV over 15 minutes on day 1. In both arms, treatment repeats every 14 days for up to 20 courses* in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 1 year and then every 3 months for 1 year.

NOTE: * Patients will be treated for three courses after hCG < 5 mIU/mL or until evidence of treatment failure (biologic progression), disease progression, or unacceptable toxicity despite dose modifications. Upon normalization of hCG (< 5 mIU/mL), patients will be treated with three additional courses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:

    • Post Molar GTN

      • For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:

        • A < 10% decrease in the human chorionic gonadotropin (hCG) level using as a reference the first value in the series of 4 values taken over a period of 3weeks (> 50 mIU/ml minimum) OR
        • A > 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml minimum) OR
        • A persistently elevated hCG level a period of 6 months or more following the initial curettage (> 50 mIU/ml minimum)
    • Choriocarcinoma

      • Histologically proven non-metastatic choriocarcinoma OR
      • Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung
  • World Health Organization (WHO) risk score 0-6
  • Patients must be willing to practice effective contraception for the duration of the study
  • White blood cell count (WBC) >= 3,000 cells/mcL
  • Granulocytes >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Creatinine =< 2.0 mg/dcL
  • Bilirubin =< 1.5 times institutional normal
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 times institutional normal
  • Alkaline phosphatase =< 3 times institutional normal
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • No patients with non-gestational choriocarcinoma
  • No patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study
  • No patients who have received prior pelvic radiation
  • No patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
  • No patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years
  • No patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
  • No patients who wish to breast-feed during treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535053

  Hide Study Locations
Locations
United States, Arizona
Gynecologic Oncology Group of Arizona Recruiting
Phoenix, Arizona, United States, 85012
Contact: Julian C. Schink    312-472-4684    jschink@nmff.org   
Principal Investigator: Julian C. Schink         
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: John H. Farley    877-602-4111      
Principal Investigator: John H. Farley         
United States, California
UC San Diego Moores Cancer Center Recruiting
LA Jolla, California, United States, 92093
Contact: Loren K. Mell    858-822-5354    cancercto@ucsd.edu   
Principal Investigator: Loren K. Mell         
Kaiser Permanente Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Contact: Scott E. Lentz    626-564-3455      
Principal Investigator: Scott E. Lentz         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
United States, Georgia
Dekalb Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Jayanthi Srinivasiah    404-501-3279      
Principal Investigator: Jayanthi Srinivasiah         
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Andrew E. Green    770-219-8800    cancerpatient.navigator@nghs.com   
Principal Investigator: Andrew E. Green         
Saint Joseph's-Candler Health System Recruiting
Savannah, Georgia, United States, 31405
Contact: William E. Richards    800-622-6877    uchealthnews@uc.edu   
Principal Investigator: William E. Richards         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403
Contact: James J. Burke    912-350-8568      
Principal Investigator: James J. Burke         
United States, Illinois
Rush - Copley Medical Center Recruiting
Aurora, Illinois, United States, 60504
Contact: Ronald E. Kimball    800-446-5532      
Principal Investigator: Ronald E. Kimball         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Seiko D. Yamada    773-834-7424      
Principal Investigator: Seiko D. Yamada         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Julian C. Schink    616-391-3050    cancer@northwestern.edu   
Principal Investigator: Julian C. Schink         
Sudarshan K Sharma MD Limted-Gynecologic Oncology Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Sudarshan K. Sharma    630-856-6757      
Principal Investigator: Sudarshan K. Sharma         
Good Samaritan Regional Health Center Active, not recruiting
Mount Vernon, Illinois, United States, 62864
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Ronald E. Kimball    800-446-5532      
Principal Investigator: Ronald E. Kimball         
United States, Indiana
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Elkhart Clinic Recruiting
Elkhart, Indiana, United States, 46514-2098
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Michiana Hematology Oncology PC-Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Saint Vincent Oncology Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Gregory P. Sutton    317-338-2194      
Principal Investigator: Gregory P. Sutton         
Community Howard Regional Health Recruiting
Kokomo, Indiana, United States, 46904
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Indiana University Health La Porte Hospital Recruiting
La Porte, Indiana, United States, 46350
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Franciscan Saint Anthony Health-Michigan City Recruiting
Michigan City, Indiana, United States, 46360
Contact: Ronald E. Kimball    800-446-5532      
Principal Investigator: Ronald E. Kimball         
Michiana Hematology Oncology PC-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Saint Joseph Regional Medical Center-Mishawaka Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Cancer Care Partners LLC Terminated
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Plymouth Recruiting
Plymouth, Indiana, United States, 46563
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Michiana Hematology Oncology PC-South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
South Bend Clinic Recruiting
South Bend, Indiana, United States, 46617
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46628
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Michiana Hematology Oncology-PC Westville Recruiting
Westville, Indiana, United States, 46391
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
United States, Iowa
Mercy Medical Center-Sioux City Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
Saint Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
Siouxland Hematology Oncology Associates Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
United States, Kentucky
Saint Elizabeth Medical Center South Recruiting
Edgewood, Kentucky, United States, 41017
Contact: James C. Pavelka    513-862-2230      
Principal Investigator: James C. Pavelka         
United States, Maine
Maine Medical Center-Bramhall Campus Recruiting
Portland, Maine, United States, 04102
Contact: Christopher J. Darus    207-885-7565      
Principal Investigator: Christopher J. Darus         
United States, Maryland
University of Maryland Greenebaum Cancer Center Withdrawn
Baltimore, Maryland, United States, 21201-1595
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Neil S. Horowitz    617-724-5200      
Principal Investigator: Neil S. Horowitz         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Neil S. Horowitz    617-724-5200      
Principal Investigator: Neil S. Horowitz         
United States, Michigan
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord    269-373-7458      
Principal Investigator: Raymond S. Lord         
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
Lakeland Hospital Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Michael W. Method    574-237-1328      
Principal Investigator: Michael W. Method         
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Minnesota Oncology Hematology PA-Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Saint John's Hospital - Healtheast Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
New Ulm Medical Center Recruiting
New Ulm, Minnesota, United States, 56073
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Metro-Minnesota CCOP Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Saint Francis Regional Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Minnesota Oncology and Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
United States, Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center Active, not recruiting
Bolivar, Missouri, United States, 65613
CoxHealth Cancer Center Active, not recruiting
Branson, Missouri, United States, 65616
Mercy Hospital-Joplin Active, not recruiting
Joplin, Missouri, United States, 64804
Freeman Health System Active, not recruiting
Joplin, Missouri, United States, 64804
Phelps County Regional Medical Center Active, not recruiting
Rolla, Missouri, United States, 65401
Saint John's Clinic-Rolla-Cancer and Hematology Active, not recruiting
Rolla, Missouri, United States, 65401
Saint John's Mercy Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63141
Saint Louis Cancer and Breast Institute-South City Active, not recruiting
Saint Louis, Missouri, United States, 63109
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Recruiting
Springfield, Missouri, United States, 65802
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
Mercy Hospital Springfield Active, not recruiting
Springfield, Missouri, United States, 65804
CoxHealth South Hospital Active, not recruiting
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic Active, not recruiting
Billings, Montana, United States, 59107-7000
Saint Vincent Healthcare Active, not recruiting
Billings, Montana, United States, 59101
Montana Cancer Consortium CCOP Active, not recruiting
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital Active, not recruiting
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center Active, not recruiting
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute Active, not recruiting
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital Active, not recruiting
Helena, Montana, United States, 59601
Kalispell Regional Medical Center Active, not recruiting
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital Active, not recruiting
Missoula, Montana, United States, 59802
Montana Cancer Specialists Active, not recruiting
Missoula, Montana, United States, 59802
United States, Nevada
Women's Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Nicola M. Spirtos    702-851-4672      
Principal Investigator: Nicola M. Spirtos         
United States, New York
State University of New York Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Ovadia Abulafia    718-270-8216    sima.terebelo@downstate.edu   
Principal Investigator: Ovadia Abulafia         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Elizabeth L. Jewell    212-639-7202      
Principal Investigator: Elizabeth L. Jewell         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Robert V. Higgins    704-355-2884      
Principal Investigator: Robert V. Higgins         
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Recruiting
Akron, Ohio, United States, 44304
Contact: Vivian E. von Gruenigen    330-375-6101      
Principal Investigator: Vivian E. von Gruenigen         
Strecker Cancer Center-Belpre Recruiting
Belpre, Ohio, United States, 45714
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Columbus CCOP Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Columbus Oncology and Hematology Associates Inc Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43228
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: David M. O'Malley    866-627-7616    osu@emergingmed.com   
Principal Investigator: David M. O'Malley         
Delaware Health Center-Grady Cancer Center Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Peter G. Rose    866-223-8100      
Principal Investigator: Peter G. Rose         
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Knox Community Hospital Recruiting
Mount Vernon, Ohio, United States, 43050
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Springfield Regional Medical Center Recruiting
Springfield, Ohio, United States, 45505
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Saint Ann's Hospital Recruiting
Westerville, Ohio, United States, 43081
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
Genesis HealthCare System Recruiting
Zanesville, Ohio, United States, 43701
Contact: John P. Kuebler    800-446-5532      
Principal Investigator: John P. Kuebler         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
Tulsa Cancer Institute Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
United States, Pennsylvania
Abington Memorial Hospital Active, not recruiting
Abington, Pennsylvania, United States, 19001
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822-2001
Contact: James R. Bosscher    570-271-5251    ehicks@sprg.mercy.net   
Principal Investigator: James R. Bosscher         
Geisinger Medical Center-Cancer Center Hazelton Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: James R. Bosscher    570-271-5251    ehicks@sprg.mercy.net   
Principal Investigator: James R. Bosscher         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Enrique Hernandez    215-728-2983      
Principal Investigator: Enrique Hernandez         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Robert P. Edwards    412-647-2811      
Principal Investigator: Robert P. Edwards         
Geisinger Medical Group Recruiting
State College, Pennsylvania, United States, 16801
Contact: James R. Bosscher    570-271-5251    ehicks@sprg.mercy.net   
Principal Investigator: James R. Bosscher         
Geisinger Wyoming Valley Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: James R. Bosscher    570-271-5251    ehicks@sprg.mercy.net   
Principal Investigator: James R. Bosscher         
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Carolyn K. McCourt    401-274-1122      
Principal Investigator: Carolyn K. McCourt         
United States, Tennessee
University of Tennessee - Knoxville Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Larry C. Kilgore    865-544-9773      
Principal Investigator: Larry C. Kilgore         
United States, Texas
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: David S. Miller    214-648-7097      
Principal Investigator: David S. Miller         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David S. Miller    214-648-7097      
Principal Investigator: David S. Miller         
United States, Wisconsin
Aurora Cancer Care-Grafton Recruiting
Grafton, Wisconsin, United States, 53024
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311-6519
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Vince Lombardi Cancer Clinic-Marinette Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Aurora Sinai Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Cancer Center of Western Wisconsin Recruiting
New Richmond, Wisconsin, United States, 54017
Contact: Matthew P. Boente    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Matthew P. Boente         
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Vince Lombardi Cancer Clinic-Sheboygan Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Aurora Medical Center in Summit Recruiting
Summit, Wisconsin, United States, 53066
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Vince Lombardi Cancer Clinic Recruiting
Two Rivers, Wisconsin, United States, 54241
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
Aurora Women's Pavilion of Aurora West Allis Medical Center Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Peter R. Johnson    800-252-2990      
Principal Investigator: Peter R. Johnson         
United States, Wyoming
Rocky Mountain Oncology Active, not recruiting
Casper, Wyoming, United States, 82609
Welch Cancer Center Active, not recruiting
Sheridan, Wyoming, United States, 82801
Canada, Ontario
Odette Cancer Centre- Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Allan L. Covens    416-480-5000      
Principal Investigator: Allan L. Covens         
Japan
Tohoku University School of Medicine Recruiting
Sendai, Aoba-ku, Japan, 980-8574
Contact: Nobuo Yaegashi       med-som@bureau.tohoku.ac.jp   
Principal Investigator: Nobuo Yaegashi         
Kure National Hospital Recruiting
Kure, Hiroshima, Japan, 737
Contact: Takashi Sawasaki    (0823) 22-3111      
Principal Investigator: Takashi Sawasaki         
Iwate Medical University School of Medicine Recruiting
Morioka, Iwate, Japan, 020-8505
Contact: Toru Sugiyama    019-651-5111      
Principal Investigator: Toru Sugiyama         
Niigata University Medical and Dental Hospital Recruiting
Niigata City, Niigata, Japan, 951-8520
Contact: Takayuki Enomoto    81-025-223-6161      
Principal Investigator: Takayuki Enomoto         
University of the Ryukyus Hospital-Col Health Scnc Recruiting
Nakagami-gun, Okinawa, Japan, 903-0215
Contact: Yoichi Aoki    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Yoichi Aoki         
Kagoshima City Hospital Recruiting
Kagoshima City, Kagoshima, Japan, 892-8580
Contact: Masayuki Hatae    011 81 099 224 2101      
Principal Investigator: Masayuki Hatae         
Kinki University Recruiting
Osaka, Osaka, Japan, 589 8511
Contact: Masaki Mandai    072-366-0221      
Principal Investigator: Masaki Mandai         
Saitama Medical University International Medical Center Recruiting
Saitama, Japan, 350-1298
Contact: Keiichi Fujiwara    81-49-276-2028      
Principal Investigator: Keiichi Fujiwara         
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam City, Kyeonggi-do, Korea, Republic of, 463-707
Contact: Jae Hong No    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Jae Hong No         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joo-Hyun Nam    011-82-760-2384      
Principal Investigator: Joo-Hyun Nam         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Jae-Hoon Kim       clinical.trial@bms.com   
Principal Investigator: Jae-Hoon Kim         
Korea Cancer Center Hospital Recruiting
Seoul, Korea, Republic of, 139-706
Contact: Moon-Hong Kim    011-82-02-9702-114      
Principal Investigator: Moon-Hong Kim         
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Julian Schink Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01535053     History of Changes
Other Study ID Numbers: GOG-0275, NCI-2012-00250, CDR0000725211, GOG-0275, GOG-0275, U10CA027469
Study First Received: February 14, 2012
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Choriocarcinoma
Hydatidiform Mole
Trophoblastic Neoplasms
Gestational Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Pregnancy Complications
Dactinomycin
Methotrexate
Calcium, Dietary
Leucovorin
Levoleucovorin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Bone Density Conservation Agents
Physiological Effects of Drugs
Vitamin B Complex

ClinicalTrials.gov processed this record on July 28, 2014