Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

Completed · Phase 3

Conditions studied: Good Prognosis Metastatic Gestational Trophoblastic Tumor, Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Uterine Corpus Choriocarcinoma

In brief

Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.

Key facts

Study ID

NCT00003702

Run by

Gynecologic Oncology Group

People needed

240

Starts

1999-06-01

Last updated by the study team

2018-05-15

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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