Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
Condition: Good Prognosis Metastatic Gestational Trophoblastic Tumor; Hydatidiform Mole; Non-Metastatic Gestational Trophoblastic Tumor; Uterine Corpus Choriocarcinoma
MeSH terms: Choriocarcinoma; Trophoblastic Neoplasms; Gestational Trophoblastic Disease; Hydatidiform Mole
Intervention: Dactinomycin; Methotrexate
Intervention description: Given IV; Given intramuscularly
Intervention MeSH terms: Dactinomycin; Cactinomycin; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: Female
Healthy volunteers: No

Summary:

      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.
    

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