Combination Chemotherapy for Adrenocortical Cancer
Name of the Trial
Phase II Study of Combination Chemotherapy Comprising Tariquidar, Mitotane, Doxorubicin, Vincristine, and Etoposide and Surgery in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (NCI-04-C-0011). See the protocol abstract.
Dr. Antonio Tito Fojo and Dr. Michael Menefee (protocol chair), NCI Center for Cancer Research.
Why Is This Trial Important?
Adrenocortical carcinoma is cancer that develops in the outside layer (cortex) of the adrenal gland. Surgery is the preferred method for treating adrenocortical carcinoma. However, patients with advanced cancer may have tumors that cannot be completely removed by surgery. Chemotherapy may be used alone or in combination with surgery to treat advanced adrenocortical carcinoma.
A drug called tariquidar may make cancer cells more sensitive to chemotherapy. Tariquidar inhibits a protein called p-glycoprotein, which is found in high amounts on adrenocortical carcinoma cells. This trial combines tariquidar with chemotherapy to treat adrenocortical carcinoma. Selected patients may undergo surgery after achieving their best response to chemotherapy.
"This trial is the second of two trials to evaluate the effect of inhibiting p-glycoprotein in the treatment of adrenocortical cancer," said Dr. Menefee. "The first trial added the drug mitotane to combination chemotherapy, and with this trial we are adding tariquidar, a more potent p-glycoprotein inhibitor, to the mitotane and chemotherapy regimen.
"We believe that effective inhibition of p-glycoprotein may increase the response rate of systemic chemotherapy in adrenocortical carcinoma," Dr. Menefee explained.
Who Can Join This Trial?
Researchers seek to enroll up to 47 patients aged 18 and over who have recurrent, metastatic, or primary unresectable adrenocortical carcinoma. See the list of eligibility criteria.
Where Is This Trial Taking Place?
This study is taking place at the NIH Clinical Center in Bethesda, Md.
For more information, call the NCI Clinical Studies Support Center (CSSC) at 1-888-NCI-1937. The CSSC provides information about cancer trials taking place on the NIH campus in Bethesda, Md. The call is toll free and confidential.