Clinical Trial: Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Gynecologic Oncology Group
Current Primary Outcome:
- Frequency and severity of observed adverse effects as assessed by the Gynecologic Oncology Group (GOG) toxicity criteria [ Time Frame: Up to 1 year ]
- Frequency of objective (complete) response as measured by normal beta HCG levels [ Time Frame: Up to 1 year ]
Original Primary Outcome:
Current Secondary Outcome: Cure rate as measured by normal beta HCG levels [ Time Frame: Up to a minimum of 1 year ]
Original Secondary Outcome:
Information By: Gynecologic Oncology Group
Dates:
Date Received: November 1, 1999
Date Started: June 1999
Date Completion:
Last Updated: February 9, 2016
Last Verified: February 2016
