Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

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
• •Performance status - GOG 0-2
• •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 entry
• •No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer
• •No prior chemotherapy for gestational trophoblastic neoplasia
• •No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor