RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. It is not yet known whether methotrexate is more effective than
dactinomycin in treating patients with gestational trophoblastic neoplasia.
PURPOSE: Randomized phase III trial to compare the effectiveness of methotrexate with that of
dactinomycin in treating patients who have gestational trophoblastic neoplasia.
- 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
- Arm II: Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of
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.
PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 4 years.
DISEASE CHARACTERISTICS:
- Histologically proven low-risk gestational trophoblastic neoplasia (persistent
hydatidiform mole or choriocarcinoma), defined as 1 of the following:
- Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over
3 weekly titers
- Greater than 20% sustained rise in beta HCG titer over two consecutive weeks
- Persistently elevated beta HCG titer more than 4 months after initial curettage
(greater than 5 mIU/mL minimum)
- Histologically proven nonmetastatic choriocarcinoma
- Metastases to vagina, parametria, or lung (if no single pulmonary lesion is
greater than 2 cm)
- WHO score 0-6 (not including blood group or CT lung)
- No histologically confirmed placental site pseudotumor
- Must have undergone at least 1 uterine curettage
- Previously untreated disease
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1. 5 times upper limit of normal (ULN)
- SGPT and SGOT no greater than 3 times ULN
- Alkaline phosphatase no greater than 3 times ULN
- No significant prior abnormal hepatic function
Renal:
- Creatinine no greater than 2. 0 mg/dL
- No significant prior abnormal renal function
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for one year after study
entry
- No other prior or concurrent malignancies within the past 5 years except
nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for gestational trophoblastic neoplasia
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- No concurrent curettage except as needed to control vaginal bleeding or to rule out
placental site pseudotumor
Kagoshima City Hospital, Kagoshima City, Kagoshima 892-8580, Japan
Keio University School of Medicine, Shinjuku-ku 160-8582, Japan
Kobe Medical Center, Kobe 654-0155, Japan
National Kyushu Cancer Center, Minami-ku 811 1395, Japan
Tottori University Hospital, Tottori 680-8550, Japan
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama 35294, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California 92868, United States
Todd Cancer Institute at Long Beach Memorial Medical Center, Long Beach, California 90801, United States
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California 90089-9181, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus, New Britain, Connecticut 06050, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center, Lakeland, Florida 33805, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States
Evanston Northwestern Healthcare - Evanston Hospital, Evanston, Illinois 60201-1781, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois 62781-0001, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States
Elkhart General Hospital, Elkhart, Indiana 46515, United States
Howard Community Hospital, Kokomo, Indiana 46904, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States
Memorial Hospital of South Bend, South Bend, Indiana 46601, United States
Saint Joseph Regional Medical Center, South Bend, Indiana 46617, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa 52242-1002, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky 40536-0293, United States
Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana 71315-3198, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts 01199, United States
Tufts-NEMC Cancer Center, Boston, Massachusetts 02111, United States
Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan 49085, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan 48073, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65802, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri 65807, United States
Saint Louis University Cancer Center, Saint Louis, Missouri 63110, United States
St. John's Regional Health Center, Springfield, Missouri 65804, United States
Women's Cancer Center - Lake Mead, Las Vegas, Nevada 89102, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey 08043, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States
SUNY Downstate Medical Center, Brooklyn, New York 11203, United States
Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States
Hope A Women's Cancer Center, Asheville, North Carolina 28801, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio 43210-1240, United States
Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5065, United States
Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio 44111, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio 45409, United States
Lake/University Ireland Cancer Center, Mentor, Ohio 44060, United States
Mount Carmel Health - West Hospital, Columbus, Ohio 43222, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio 43214-3998, United States
St. Rita's Medical Center, Lima, Ohio 45801, United States
Edmond Odette Cancer Centre at Sunnybrook, Toronto, Ontario M4N 3M5, Canada
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania 19612-6052, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania 19001, United States
Brooke Army Medical Center, Fort Sam Houston, Texas 78234, United States
Parkland Memorial Hospital, Dallas, Texas 75235, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390, United States
Allenmore Hospital, Tacoma, Washington 98405, United States
Auburn Regional Center for Cancer Care, Auburn, Washington 98002, United States
CCOP - Northwest, Tacoma, Washington 98405, United States
Good Samaritan Cancer Center, Puyallup, Washington 98372, United States
MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma, Washington 98405, United States
Providence Centralia Hospital, Centralia, Washington 98531-9027, United States
Providence St. Peter Hospital Regional Cancer Center, Olympia, Washington 98506-5166, United States
St. Clare Hospital, Tacoma, Washington 98499, United States
St. Francis Hospital, Federal Way, Washington 98003, United States
St. Joseph Medical Center at Franciscan Health System, Tacoma, Washington 98405-3004, United States
