A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-Day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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; 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 1 criterion
for GTN defined as:

- A < 10% decrease in the human chorionic gonadotropin (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)

- 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)

- A persistently elevated hCG level for a period of 6 months or more
following the initial curettage (> 50 mIU/mL minimum)

- Choriocarcinoma meeting 1 of the following criteria:

- Histologically proven non-metastatic choriocarcinoma

- 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

- No patients with non-gestational choriocarcinoma

- No patients with placental-site trophoblastic tumor (PSTT) or epithelioid
trophoblastic tumor (ETT)

PATIENT CHARACTERISTICS:

- Patients must be willing to practice effective contraception for the duration of the
study

- White blood cell (WBC) ≥ 3,000 cells/mcL

- Granulocytes ≥ 1,500/mcL

- Platelets ≥ 100,000/mcL

- Creatinine ≤ 2.0 mg/dcL

- Bilirubin ≤ 1.5 times institutional normal

- ALT and AST ≤ 3 times institutional normal

- Alkaline phosphatase ≤ 3 times institutional normal

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information

- 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

- No patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4

- No patients whose circumstances at the time of study entry do not permit completion
of the study or required follow-up

- No patients who wish to breast-feed during treatment

PRIOR CONCURRENT THERAPY:

- No patients who have previously been treated with cytotoxic chemotherapy

- Patients who received prior low-dose methotrexate for treatment of an ectopic
pregnancy will be eligible for this study

- No patients who have received prior pelvic radiation

- Patients are excluded if their previous cancer treatment contraindicates this
protocol therapy