Phase II Trial Of TAXOTERE + TARCEVA™ To Treat HRPC In Men ≥ 65 Years Of Age
- Determine the response rate and response duration in older patients with progressive
hormone refractory prostate cancer treated with docetaxel and erlotinib.
- Determine the safety of this regimen in these patients.
- Evaluate the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Initial combination therapy: Patients receive docetaxel IV over 1 hour on day 1 and
oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for up to 9
courses in the absence of disease progression or unacceptable toxicity. Patients with
responding disease receive 3 additional courses beyond maximal response.
- Extension phase: After 9 courses of initial combination therapy, patients achieving a
complete response, partial response, or stable disease receive 8 courses of erlotinib
alone (total of 17 courses of study treatment).
Quality of life is assessed at baseline, day 1 of each course, and at the end of study
treatment. For patients in the extension phase, quality of life is also assessed on day 1 of
courses 10, 12, 14, and 16.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 24 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
During the primary phase of the study (cycles 1-9), response to the combination of Taxotere® and Tarceva™ treatment will be assessed at the end of every 3 treatment cycles (9 weeks) with the standard procedures such as physical examination, CT scans, bone scans, MRI and laboratory results. For those patients that continue on in the extension phase of the study (cycles 10 -17), response to Tarceva™ is to be assessed at the end of 4 treatment cycles (end of cycle 13).
Allan Pantuck, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center||Los Angeles, California 90048-1865|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|