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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003702 |
RATIONALE: 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.
PURPOSE: Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia.
Condition | Intervention | Phase |
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Gestational Trophoblastic Tumor |
Drug: dactinomycin Drug: methotrexate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Manangement for Low Risk Gestational Trophoblastic Neoplasia |
Estimated Enrollment: | 216 |
Study Start Date: | June 1999 |
Estimated Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta human chorionic gonadotropin (HCG) titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
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Drug: methotrexate
Given intramuscularly
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Arm II: Experimental
Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.
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Drug: dactinomycin
Given IV
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OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
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.
PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 4 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Raymond Osborne, MD, FRCSC, MBA | Edmond Odette Cancer Centre at Sunnybrook |
Study Chair: | Higinia R. Cardenes, MD, PhD | Indiana University Melvin and Bren Simon Cancer Center |
Study ID Numbers: | CDR0000066809, GOG-174, ECOG-G174 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003702 |
Health Authority: | United States: Federal Government |
hydatidiform mole uterine choriocarcinoma nonmetastatic gestational trophoblastic tumor good prognosis metastatic gestational trophoblastic tumor |
Folic Acid Gestational trophoblastic disease Pregnancy Complications Dactinomycin Neoplasms, Germ Cell and Embryonal Gestational Trophoblastic Neoplasms |
Hydatidiform Mole Choriocarcinoma Methotrexate Trophoblastic Neoplasms Nevus |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Pregnancy Complications, Neoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists |
Abortifacient Agents, Nonsteroidal Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Protein Synthesis Inhibitors Anti-Bacterial Agents Neoplasms Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |