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

Choriocarcinoma research study

What is the primary objective of this study?

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, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.

Who is eligible to participate?

Inclusion Criteria: - 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 (as defined below); 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 the criteria for GTN defined as: - A < 10% decrease in the 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) OR - 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) OR - A persistently elevated hCG level a period of 6 months or more following the initial curettage (> 50 mIU/ml minimum) - Choriocarcinoma - Histologically proven non-metastatic choriocarcinoma OR - 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 - Patients must be willing to practice effective contraception for the duration of the study - White blood cell count (WBC) >= 3,000 cells/mcL - Granulocytes >= 1,500/mcL - Platelets >= 100,000/mcL - Creatinine =< 2.0 mg/dcL - Bilirubin =< 1.5 x institutional normal - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x institutional normal - Alkaline phosphatase =< 3 x institutional normal - Patients who have met the pre-entry requirements - Before enrolling a patient, the institution must verify the availability of an adequate supply of methotrexate for a full course of therapy - Patients must have signed an approved informed consent and authorization permitting release of personal health information Exclusion Criteria: - Patients who do not have GTN - Patients with non-gestational choriocarcinoma - Patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study - Patients who have received prior pelvic radiation - Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) - Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4 - 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; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy - Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up - Patients who wish to breast-feed during treatment

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Choriocarcinoma

FIGO Stage I Gestational Trophoblastic Tumor

FIGO Stage II Gestational Trophoblastic Tumor

FIGO Stage III Gestational Trophoblastic Tumor

Hydatidiform Mole

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:DactinomycinGiven IV

Drug:Leucovorin CalciumGiven PO

Drug:MethotrexateGiven IV and IM

Other:Quality-of-Life AssessmentAncillary studies

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Arm I (dactinomcin)Patients receive dactinomycin IV over 15 minutes on day 1.

Arm II (leucovorin calcium and methotrexate)Patients receive methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.

Study Status

Active, not recruiting

Start Date: June 18, 2012

Completed Date:

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Complete response vs treatment failure

Secondary Outcome: Overall QOL as measured by Functional Assessment of Cancer Therapy - General (FACT-G)

Study sponsors, principal investigator, and references

Principal Investigator: Julian Schink

Lead Sponsor: Gynecologic Oncology Group

Collaborator: National Cancer Institute (NCI)

More information:https://clinicaltrials.gov/show/NCT01535053

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