A Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)
Adrenocortical carcinoma is a rare cancer with an incidence of 1.5 to 2 per million people
in the United States. Surgery is the only potentially curative option. Current systemic
therapy, either Mitotane or chemotherapy, typically gives response rates of 20% or less.
This study is designed to see if the newer targeted therapy, Iressa, may be of benefit for
patients with this fatal disease.
Patients with nonresectable adrenocortical cancer who have progressed on at least one other
form of systemic therapy (Mitotane or chemotherapy) will be given Iressa 250 mg by mouth
daily until disease progression. This is a standard two-stage Phase II clinical trial.
Eighteen patients with measurable disease will be enrolled in the first stage. If there is
at least one responder, then an additional nine patients with measurable disease will be
enrolled for a total of 27 patients with measurable disease. Up to six patients without
measurable disease may be enrolled at any point in this study. Iressa will be provided free
for all study participants.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
The primary objective of this study is to measure the objective response rate by RECIST (radiographic) criteria of nonresectable adrenocortical cancer to ZD1839
Vivek Samnotra, MD
Dartmouth-Hitchcock Medical Center
United States: Institutional Review Board
|Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|The University of Texas M.D. Anderson Cancer Center||Houston, Texas|
|Kentuckiana Cancer Institute PLLC||Louisville, Kentucky 40202|