Know Cancer

forgot password

A Randomized Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Manangement for Low Risk Gestational Trophoblastic Neoplasia

Phase 3
Not Enrolling
Gestational Trophoblastic Tumor

Thank you

Trial Information

A Randomized Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Manangement for Low Risk 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
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.

Inclusion Criteria


- 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



- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Creatinine no greater than 2.0 mg/dL

- No significant prior abnormal renal function


- Not pregnant or nursing

- Fertile patients must use effective contraception during and for one year after study

- No other prior or concurrent malignancies within the past 5 years except
nonmelanomatous skin cancer


Biologic therapy:

- Not specified


- No prior chemotherapy for gestational trophoblastic neoplasia

Endocrine therapy:

- Not specified


- Not specified


- See Disease Characteristics

- No concurrent curettage except as needed to control vaginal bleeding or to rule out
placental site pseudotumor

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Frequency of objective (complete) response as measured by normal beta human chorionic gonadotropin (HCG) levels

Safety Issue:


Principal Investigator

Raymond Osborne, MD, FRCSC, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

Odette Cancer Centre at Sunnybrook


United States: Federal Government

Study ID:




Start Date:

June 1999

Completion Date:

Related Keywords:

  • Gestational Trophoblastic Tumor
  • hydatidiform mole
  • uterine choriocarcinoma
  • nonmetastatic gestational trophoblastic tumor
  • low risk metastatic gestational trophoblastic tumor
  • Neoplasms
  • Trophoblastic Neoplasms
  • Gestational Trophoblastic Neoplasms



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