A Randomized Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Manangement for Low Risk Gestational Trophoblastic Neoplasia
OBJECTIVES:
- Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response
rate, in patients with low-risk gestational trophoblastic neoplasia.
- Compare the toxicity of these regimens in these patients.
- Determine whether the definition of persistent gestational trophoblastic neoplasia is
accurate (as determined by the likelihood that the beta human chorionic gonadotropin
[HCG] titer would decline on the day treatment is initiated).
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive methotrexate intramuscularly once weekly in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence
of disease progression or unacceptable toxicity.
All patients continue on treatment until 1 beta human chorionic gonadotropin (HCG) titer is
below the institutional normal. Patients then receive 1 additional consolidation treatment.
Patients are followed every 4 weeks for 1 year.
PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 4 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Frequency of objective (complete) response as measured by normal beta human chorionic gonadotropin (HCG) levels
No
Raymond Osborne, MD, FRCSC, MBA
Study Chair
Odette Cancer Centre at Sunnybrook
United States: Federal Government
CDR0000066809
NCT00003702
June 1999
Name | Location |
---|---|
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Evanston Northwestern Healthcare - Evanston Hospital | Evanston, Illinois 60201-1781 |
Tufts-NEMC Cancer Center | Boston, Massachusetts 02111 |
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Todd Cancer Institute at Long Beach Memorial Medical Center | Long Beach, California 90801 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Women's Cancer Center - Lake Mead | Las Vegas, Nevada 89102 |
Hope A Women's Cancer Center | Asheville, North Carolina 28801 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida 33805 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
St. Francis Hospital | Federal Way, Washington 98003 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
St. Joseph Medical Center at Franciscan Health System | Tacoma, Washington 98405-3004 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Providence Centralia Hospital | Centralia, Washington 98531-9027 |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham, Alabama 35294 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Auburn Regional Center for Cancer Care | Auburn, Washington 98002 |