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

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