A Phase II Study Evaluating the Efficacy of Iressa Plus Etoposide in Patients With Advanced Hormone Refractory Prostate Cancer
- Determine the activity of gefitinib and etoposide, in terms of overall response rate,
in patients with hormone-refractory advanced prostate cancer previously treated with
- Determine the toxicity of this regimen in these patients.
- Determine whether related biomarkers can help predict response in patients treated with
OUTLINE: This is a nonrandomized study.
Patients receive oral gefitinib once daily on days 1-28 and oral etoposide once daily on
days 1-14. Treatment repeats every 28 days in the absence of disease progression or
Patients undergo blood sample collection at baseline and periodically during study for
correlative studies. Blood samples are analyzed by enzyme-linked immunosorbent assays for
biomarkers (e.g., VEGF, basic fibroblast growth factor, and anti-EGFR antibody titers) in
order to determine whether one or more of these biomarkers can predict response.
After completion of study therapy, patients are followed periodically.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate as measured by RECIST criteria
If there is at least 1 response, then 7 additional patients will be enrolled. If there are 4 or more responders overall, then the combination will be considered active and warrant further study.
After 14 patients are enrolled
Ralph Hauke, MD
University of Nebraska
United States: Food and Drug Administration
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|