Hydatidiform Mole Clinical Trial
Official title:
A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
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.
OBJECTIVES:
I. Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response
rate, in patients with low-risk gestational trophoblastic neoplasia.
II. Compare the toxicity of these regimens in these patients. III. Determine whether the
definition of persistent gestational trophoblastic neoplasia is accurate (as determined by
the likelihood that the beta human chorionic gonadotropin [HCG] titer would decline on the
day treatment is initiated).
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive methotrexate intramuscularly once weekly in the absence of disease
progression or unacceptable toxicity.
ARM II: Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of
disease progression or unacceptable toxicity. All patients continue on treatment until 1 beta
human chorionic gonadotropin (HCG) titer is below the institutional normal. Patients then
receive 1 additional consolidation treatment.
Patients are followed every 4 weeks for 1 year.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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