A Phase II Study Evaluating the Efficacy of Iressa Plus Etoposide in Patients With Advanced Hormone Refractory Prostate Cancer
OBJECTIVES:
Primary
- Determine the activity of gefitinib and etoposide, in terms of overall response rate,
in patients with hormone-refractory advanced prostate cancer previously treated with
docetaxel-based therapy.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine whether related biomarkers can help predict response in patients treated with
this regimen.
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
unacceptable toxicity.
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.
Interventional
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
No
Ralph Hauke, MD
Principal Investigator
University of Nebraska
United States: Food and Drug Administration
285-03
NCT00483561
January 2004
Name | Location |
---|---|
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |