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


Phase 3
N/A
N/A
Not Enrolling
Female
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


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.

Inclusion 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

Type of Study:

Interventional

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:

No

Principal Investigator

Raymond Osborne, MD, FRCSC, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

Odette Cancer Centre at Sunnybrook

Authority:

United States: Federal Government

Study ID:

CDR0000066809

NCT ID:

NCT00003702

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

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois  60201-1781
Tufts-NEMC Cancer CenterBoston, Massachusetts  02111
Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
St. Rita's Medical CenterLima, Ohio  45801
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
CCOP - NorthwestTacoma, Washington  98405-0986
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Todd Cancer Institute at Long Beach Memorial Medical CenterLong Beach, California  90801
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Women's Cancer Center - Lake MeadLas Vegas, Nevada  89102
Hope A Women's Cancer CenterAsheville, North Carolina  28801
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Parkland Memorial HospitalDallas, Texas  75235
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health SystemTacoma, Washington  98405-3004
Allenmore HospitalTacoma, Washington  98411-0414
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Providence Centralia HospitalCentralia, Washington  98531-9027
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Auburn Regional Center for Cancer CareAuburn, Washington  98002