Docetaxel and Erlotinib in Treating Older Patients With Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with erlotinib works in treating older patients with progressive prostate cancer that has not responded to hormone therapy.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of TAXOTERE + TARCEVA™ To Treat HRPC In Men ≥ 65 Years Of Age|
- Response [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]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).
- Safety and tolerability based on adverse events, laboratory tests and physical exams [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2004|
|Study Completion Date:||March 2008|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Experimental: Taxotere plus Tarceva
Patients receive Tarceva 150 mg daily for 21 consecutive days (one treatment cycle). In addition, all patients will receive single agent Taxotere 60 mg/m2 IV over 1 hour infusion every 21 ± 2 days and have it administered on day 1.
Taxotere + Tarceva to be taken for three cycles past maximal response or until one of the following occurs: 1) a drug-related toxicity requiring discontinuation, 2) disease progression, or 3) for a maximum of 9 cycles.
Upon completion of 9 cycles of Taxotere plus Tarceva, patients showing evidence of objective response (CR, PR or stable disease) may continue in the extension phase of the study and receive treatment with Tarceva alone. Treatment response evaluated after four cycles of Tarceva treatment(immediately prior to cycle 14). Patients with progression of disease will be taken off study. Responding and stable disease patients will remain on study for up to 8 extension-phase cycles for a total of 17 cycles.
Administered as an IV infusion of 60m/m2 over a 1-hour period, once every 21 ± 2 days
Other Name: TaxotereDrug: erlotinib hydrochloride
Will be taken at a starting daily dose of 150mg
Other Name: Tarceva
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087035
|United States, California|
|Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, Washington|
|University Cancer Center at University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|Study Chair:||Allan Pantuck, MD||Jonsson Comprehensive Cancer Center|