Methotrexate or Dactinomycin in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

Status: Recruiting
Phase: Phase 3
Diagnosis: GYN:Other Cancer
NCT ID: NCT01535053 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Neil Horowitz, MD, Brigham and Women's Hospital

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org

Eligibility Criteria

DISEASE CHARACTERISTICS: - Patients who meet International Federation of Gynecology and Obstetrics (FIGO) Stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma; patients may have had a second curettage but must still meet GTN criteria below: - Post Molar GTN; for the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet 1 criterion for GTN defined as: - A < 10% decrease in the human chorionic gonadotropin (hCG) level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (> 50 mIU/mL minimum) - A > 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (> 50 mIU/mL minimum) - A persistently elevated hCG level for a period of 6 months or more following the initial curettage (> 50 mIU/mL minimum) - Choriocarcinoma meeting 1 of the following criteria: - Histologically proven non-metastatic choriocarcinoma - Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung - World Health Organization (WHO) risk score 0-6 - No patients with non-gestational choriocarcinoma - No patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) PATIENT CHARACTERISTICS: - Patients must be willing to practice effective contraception for the duration of the study - White blood cell (WBC) ≥ 3,000 cells/mcL - Granulocytes ≥ 1,500/mcL - Platelets ≥ 100,000/mcL - Creatinine ≤ 2.0 mg/dcL - Bilirubin ≤ 1.5 times institutional normal - ALT and AST ≤ 3 times institutional normal - Alkaline phosphatase ≤ 3 times institutional normal - Patients must have signed an approved informed consent and authorization permitting release of personal health information - Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years - No patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4 - No patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up - No patients who wish to breast-feed during treatment PRIOR CONCURRENT THERAPY: - No patients who have previously been treated with cytotoxic chemotherapy - Patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study - No patients who have received prior pelvic radiation - Patients are excluded if their previous cancer treatment contraindicates this protocol therapy
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