Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
Choriocarcinoma, FIGO Stage I Gestational Trophoblastic Tumor, FIGO Stage II Gestational Trophoblastic Tumor
About this trial
This is an interventional treatment trial for Choriocarcinoma
Eligibility 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 hCG level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (> 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 x institutional normal
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x institutional normal
- Alkaline phosphatase =< 3 x institutional normal
- Patients who have met the pre-entry requirements
- Before enrolling a patient, the institution must verify the availability of an adequate supply of methotrexate for a full course of therapy
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria:
- Patients who do not have GTN
- Patients with non-gestational choriocarcinoma
- 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
- Patients who have received prior pelvic radiation
- Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
- 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; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
- Patients who wish to breast-feed during treatment
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Regional Hospital
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Cancer Center at Saint Joseph's
- Saint Joseph's Hospital and Medical Center
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- UC San Diego Moores Cancer Center
- Loma Linda University Medical Center
- Kaiser Permanente Los Angeles Medical Center
- Hartford Hospital
- The Hospital of Central Connecticut
- Northside Hospital
- Augusta University Medical Center
- Northside Hospital-Forsyth
- Dekalb Medical Center
- Northeast Georgia Medical Center-Gainesville
- Low Country Cancer Care
- Memorial Health University Medical Center
- Summit Cancer Care-Memorial
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Saint Luke's Cancer Institute - Boise
- Kootenai Health - Coeur d'Alene
- Saint Luke's Cancer Institute - Fruitland
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Rush - Copley Medical Center
- Northwestern University
- University of Chicago Comprehensive Cancer Center
- Carle on Vermilion
- Carle Physician Group-Effingham
- NorthShore University HealthSystem-Evanston Hospital
- NorthShore University HealthSystem-Glenbrook Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
- Carle Physician Group-Mattoon/Charleston
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- North Shore Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Saint Vincent Hospital and Health Care Center
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Cancer Care Partners LLC
- Memorial Regional Cancer Center Day Road
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Saint Elizabeth Healthcare Edgewood
- Maine Medical Center-Bramhall Campus
- Maine Medical Center- Scarborough Campus
- University of Maryland/Greenebaum Cancer Center
- Walter Reed National Military Medical Center
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Bronson Battle Creek
- Cancer Research Consortium of West Michigan NCORP
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Monroe Cancer Center
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- Spectrum Health Reed City Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Munson Medical Center
- Metro Health Hospital
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Central Care Cancer Center - Bolivar
- Cox Cancer Center Branson
- Freeman Health System
- Mercy Hospital Joplin
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Saint Louis Cancer and Breast Institute-South City
- Barnes-Jewish Hospital
- Washington University School of Medicine
- Mercy Hospital Saint Louis
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Women's Cancer Center of Nevada
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- State University of New York Downstate Medical Center
- Memorial Sloan Kettering Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Wake Forest University Health Sciences
- Summa Health System - Akron Campus
- Strecker Cancer Center-Belpre
- Adena Regional Medical Center
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Marietta Memorial Hospital
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Southern Ohio Medical Center
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- Saint Ann's Hospital
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Jefferson Abington Hospital
- UPMC-Heritage Valley Health System Beaver
- Geisinger Medical Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Geisinger Medical Center-Cancer Center Hazleton
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- UPMC Cancer Center at UPMC McKeesport
- UPMC-Coraopolis/Heritage Valley Radiation Oncology
- Temple University Hospital
- UPMC-Magee Womens Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC Jefferson Regional Radiation Oncology
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- UPMC Cancer Center at UPMC Northwest
- Geisinger Medical Group
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Washington Hospital Radiation Oncology
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Women and Infants Hospital
- Saint Francis Hospital
- Saint Francis Cancer Center
- University of Tennessee - Knoxville
- Dell Seton Medical Center at The University of Texas
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Providence Regional Cancer System-Aberdeen
- Cancer Care Center at Island Hospital
- Swedish Cancer Institute-Eastside Oncology Hematology
- PeaceHealth Saint Joseph Medical Center
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Providence Regional Cancer Partnership
- Swedish Cancer Institute-Issaquah
- Providence Regional Cancer System-Lacey
- PeaceHealth Saint John Medical Center
- Minor and James Medical PLLC
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- Monongalia Hospital
- Aurora Cancer Care-Southern Lakes VLCC
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- Aurora Cancer Care-Kenosha South
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Aurora Sinai Medical Center
- Cancer Center of Western Wisconsin
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Vince Lombardi Cancer Clinic-Sheboygan
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Rocky Mountain Oncology
- Big Horn Basin Cancer Center
- Billings Clinic-Cody
- Welch Cancer Center
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- CHUM - Hopital Notre-Dame
- Tohoku University School of Medicine
- Kure National Hospital
- Hokkaido University Hospital
- Iwate Medical University Hospital
- Kagoshima City Hospital
- Niigata University Medical and Dental Hospital
- University of the Ryukyus Hospital-Col Health Scnc
- Hiroshima University Hospital
- Kindai University
- Saitama Medical University International Medical Center
- Tottori University
- Samsung Medical Center
- Catholic University of Korea-Seoul Saint Mary's Hospital
- Seoul National University Bundang Hospital
- Gachon University Gil Hospital
- Asan Medical Center
- Gangnam Severance Hospital
- Seoul National University Hospital
- Korea Cancer Center Hospital
- Weston Park Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (dactinomcin)
Arm II (leucovorin calcium and methotrexate)
Patients receive dactinomycin IV over 15 minutes on day 1.
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.