A Phase III Study of Actinomycin-D versus Methotrexate to Treat Low-Risk Gestational Trophoblastic Disease

Protocol
13-108
Full Title
A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-Day Methotrexate For The Treatment of Low-Risk Gestational Trophoblastic Neoplasia(GOG 275)
Phase
III
Purpose

Gestational trophoblastic disease (GTD) is the abnormal growth of cells in a woman’s uterus that would normally develop into the placenta during pregnancy. While most GTDs are not cancerous, some do develop into cancer. GTD can usually be treated successfully.

Doctors usually treat GTD with the drug methotrexate (given as a large dose by intramuscular injection) plus leucovorin, or actinomycin-D (given intravenously). While either therapy is considered a viable option, with the choice based on side effects and convenience for the patient, this has never been directly studied.

The purpose of this Gynecologic Oncology Group study is to compare actinomycin-D and methotrexate for the treatment of low-risk GTD. Patients will be randomly assigned to receive methotrexate/leucovorin or actinomycin-D, but not both. Researchers will compare the effectiveness of these two treatments as well as patients’ quality of life.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of GTD.
  • Patients may not have received prior chemotherapy for GTD nor radiation therapy to the pelvis.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Elizabeth Jewell at 212-639-3366.

Disease(s)
Uterine (Endometrial) Cancer