Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
Condition: Choriocarcinoma; FIGO Stage I Gestational Trophoblastic Tumor; FIGO Stage II Gestational Trophoblastic Tumor; FIGO Stage III Gestational Trophoblastic Tumor; Hydatidiform Mole
MeSH terms: Choriocarcinoma; Trophoblastic Neoplasms; Gestational Trophoblastic Disease; Hydatidiform Mole
Intervention: Dactinomycin; Leucovorin Calcium; Methotrexate; Quality-of-Life Assessment
Intervention description: Given IV; Given PO; Given IV and IM; Ancillary studies
Intervention MeSH terms: Calcium, Dietary; Leucovorin; Folic Acid; Dactinomycin; Methotrexate; Calcium; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well methotrexate works compared to dactinomycin
      in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in
      chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the
      growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
      stopping them from spreading. It is not yet known whether methotrexate is more effective than
      dactinomycin in treating gestational trophoblastic disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage
             I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post
             molar GTN or choriocarcinoma (as defined below); patients may have had a second
             curettage but must still meet GTN criteria below:

               -  Post molar GTN

                    -  For the purposes of this study, patients must have undergone evacuation of a
                       complete or partial hydatidiform mole and then meet the criteria for GTN
                       defined as:

                         -  A < 10% decrease in the hCG level using as a reference the first value
                            in the series of 4 values taken over a period of 3 weeks (> 50 mIU/ml
                            minimum) OR

                         -  A > 20% sustained rise in the hCG taking as a reference the first value
                            in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml
                            minimum) OR

                         -  A persistently elevated hCG level a period of 6 months or more
                            following the initial curettage (> 50 mIU/ml minimum)

               -  Choriocarcinoma

                    -  Histologically proven non-metastatic choriocarcinoma OR

                    -  Histologically proven metastatic choriocarcinoma if the metastatic site(s)
                       is restricted to one (or more) of the following: vagina, parametrium, or
                       lung

          -  World Health Organization (WHO) risk score 0-6

          -  Patients must be willing to practice effective contraception for the duration of the
             study

          -  White blood cell count (WBC) >= 3,000 cells/mcL

          -  Granulocytes >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Creatinine =< 2.0 mg/dcL

          -  Bilirubin =< 1.5 x institutional normal

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x
             institutional normal

          -  Alkaline phosphatase =< 3 x institutional normal

          -  Patients who have met the pre-entry requirements

          -  Before enrolling a patient, the institution must verify the availability of an
             adequate supply of methotrexate for a full course of therapy

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

        Exclusion Criteria:

          -  Patients who do not have GTN

          -  Patients with non-gestational choriocarcinoma

          -  Patients who have previously been treated with cytotoxic chemotherapy; however,
             patients who received prior low-dose methotrexate for treatment of an ectopic
             pregnancy will be eligible for this study

          -  Patients who have received prior pelvic radiation

          -  Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic
             tumor (ETT)

          -  Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
             being present within the last five years; patients are also excluded if their previous
             cancer treatment contraindicates this protocol therapy

          -  Patients whose circumstances at the time of study entry do not permit completion of
             the study or required follow-up

          -  Patients who wish to breast-feed during treatment