A Study of Combination Chemotherapy and Surgical Resection in the Treatment of Adrenocortical Carcinoma: Continuous Infusion Doxorubicin, Vincristine and Etoposide With Daily Mitotane Before and After Surgical Resection
This is a study of infusional doxorubicin, vincristine, and etoposide in combination with
daily oral mitotane in patients with adrenocortical cancer. Although mitotane has been used
extensively in adrenocortical cancer and has documented single agent activity, only limited
experience is available in the use of mitotane in combination with chemotherapy. In this
trial the primary reason for using mitotane is an attempt to enhance therapeutic efficacy,
based on its documented in-vitro activity as an antagonist of P-glycoprotein. The goal of
this study is to determine the efficacy of this therapy by treating patients who are
considered candidates for surgical resection at presentation or following a response to
therapy. Following chemotherapy, patients deemed surgical candidates can undergo surgical
resection with evaluation of response. Patients responding to chemotherapy will resume the
combination treatment after surgery. Patients who do not respond will be maintained on
single agent mitotane until it is deemed ineffective.
Interventional
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
930200
NCT00001339
August 1993
August 2002
Name | Location |
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National Cancer Institute (NCI) | Bethesda, Maryland 20892 |