Current Clinical Trials

This group of patients has disease outside the uterus, but it does not have any of the adverse prognostic factors detailed in stage information. In general, these patients should be treated with single-agent chemotherapy as described for nonmetastatic disease. Patients who do not tolerate methotrexate or who become resistant to it can often be salvaged with dactinomycin. Development of intercurrent poor-risk factors dictates the need for combination chemotherapy. Cure rates should approach 100%, but approximately 40% to 50% of these patients will develop resistance to the first chemotherapeutic agent and require alternate treatment. Careful monitoring is mandatory.

Standard treatment options:

1. Methotrexate with leucovorin.[1]
2. Dactinomycin. Tumors of the placental trophoblast.
3. Primary hysterectomy followed by single-agent chemotherapy with methotrexate or dactinomycin (if patient has completed family).
4. Primary chemotherapy followed by secondary hysterectomy for persistent uterine disease (must verify that metastatic disease has totally regressed).
5. For refractory disease:
   • MAC: methotrexate plus dactinomycin plus chlorambucil.[2]

Other regimens appear to produce similar survival outcomes but have been studied less extensively or are in less common use. They are:

1. Methotrexate.[2]
2. EMA-CO: etoposide plus methotrexate plus dactinomycin and vincristine plus cyclophosphamide.[3]

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with good prognosis metastatic gestational trophoblastic tumor ¹. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site ².

References

1. Berkowitz RS, Goldstein DP, Bernstein MR: Ten year's experience with methotrexate and folinic acid as primary therapy for gestational trophoblastic disease. Gynecol Oncol 23 (1): 111-8, 1986.  [PUBMED Abstract]
   
   
2. Tumors of the placental trophoblast. In: Morrow CP, Curtin JP: Synopsis of Gynecologic Oncology. 5th ed. New York, NY: Churchill Livingstone, 1998, pp 315-353. 
   
   
3. Bagshawe KD: High-risk metastatic trophoblastic disease. Obstet Gynecol Clin North Am 15 (3): 531-43, 1988.  [PUBMED Abstract]