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.

Condition	Treatment or Intervention	Phase
Hydatidiform Mole uterine choriocarcinoma nonmetastatic gestational trophoblastic tumor good prognosis metastatic gestational trophoblastic tumor	Drug: dactinomycin  Drug: methotrexate  Procedure: chemotherapy	Phase III

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. Each patient then receives 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.

Genders Eligible for Study:  Both

Criteria

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

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
California
      Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange,  California,  92868,  United States; Recruiting
      Women's Cancer Center at Community Hospital of Los Gatos, Los Gatos,  California,  95032,  United States; Recruiting
Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80010,  United States; Recruiting
Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States; Recruiting
Kentucky
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0084,  United States; Recruiting
Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States; Recruiting
Massachusetts
      Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States; Recruiting
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
New Jersey
      Cancer Institute of New Jersey at Robert Wood Johnson University Hospital, New Brunswick,  New Jersey,  08903,  United States; Recruiting
      Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States; Recruiting
New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States; Recruiting
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States; Recruiting
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States; Recruiting
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0526,  United States; Recruiting
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44124,  United States; Recruiting
      MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland,  Ohio,  44106,  United States; Recruiting
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
      Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States; Recruiting
      Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States; Recruiting
      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Tennessee
      Gynecologic Oncology Network, Nashville,  Tennessee,  37203,  United States; Recruiting
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-9032,  United States; Recruiting
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States; Recruiting
Washington
      Multicare Medical Center, Tacoma,  Washington,  98405,  United States; Recruiting
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-0001,  United States; Recruiting
Canada, Alberta
      Tom Baker Cancer Centre - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada; Recruiting
Canada, Ontario
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting
South Africa
      Pretoria Academic Hospital, Pretoria,  0001,  South Africa; Recruiting

Study chairs or principal investigators

Raymond Osborne, MD,  Study Chair,  Toronto Sunnybrook Regional Cancer Centre   
Higinia R. Cardenes, MD, PhD,  Study Chair,  Indiana University Cancer Center   

Study ID Numbers:  CDR0000066809; GOG-174; ECOG-G174
Record last reviewed:  July 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003702
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-17