A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed gestational trophoblastic neoplasia (GTN) (complete or
partial hydatidiform mole)

- No histologically confirmed choriocarcinoma, placental site trophoblastic tumor
(PSTT), or epithelioid trophoblastic tumor (ETT) on the first curettage

- Persistent, low-risk disease (based on FIGO/WHO 2002 staging and risk scoring
criteria), as defined by 1 of the following criteria:

- Less than 10% decline in beta-human chorionic gonadotropin (hCG) levels, based
on four consecutive measurements over a 3-week period (plateau)

- Greater than 20% rise in beta-hCG levels, based on three consecutive
measurements over a 2-week period

- Beta-hCG level remains elevated above normal for ≥ 6 months

- WHO risk score ≤ 6

- Must have a clinically significant elevated beta-hCG level

- Beta-hCG > 20 miu/mL

- Non-metastatic disease

- No evidence of metastatic disease beyond the uterus by pelvic examination,
pelvic ultrasound, and chest x-ray

- No previously treated, persistent or recurrent GTN (same gestation) that have been
treated with chemotherapy

PATIENT CHARACTERISTICS:

- GOG performance status 0-1

- Fertile patients must use effective contraception during and for 6 months after
completion of study therapy

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

- No prior cancer treatment that would preclude study treatment

- No more than 1 prior curettage for current disease

- No prior hysterectomy

- No chemotherapy during the study curettage follow-up period until surgical response
has been completely determined