A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
Dactinomycin
+ Methotrexate
Urogenital Diseases+7
+ Female Urogenital Diseases and Pregnancy Complications
+ Hydatidiform Mole
Treatment Study
Summary
Study start date: June 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.240 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location