Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
Good Prognosis Metastatic Gestational Trophoblastic Tumor, Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor
About this trial
This is an interventional treatment trial for Good Prognosis Metastatic Gestational Trophoblastic Tumor
Eligibility Criteria
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
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (methotrexate)
Arm II (dactinomycin)
Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.