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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
Not Enrolling
Gestational Trophoblastic Tumor

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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



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