Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-03 @ 8:50 AM
Study NCT ID:
NCT00087035
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2004-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel and Erlotinib in Treating Older Patients With Prostate Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Phase II Trial Of TAXOTERE + TARCEVA™ To Treat HRPC In Men ≥ 65 Years Of Age
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
OBJECTIVES:
Primary
* Determine the response rate and response duration in older patients with progressive hormone refractory prostate cancer treated with docetaxel and erlotinib.
Secondary
* 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.
Primary
* Determine the response rate and response duration in older patients with progressive hormone refractory prostate cancer treated with docetaxel and erlotinib.
Secondary
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: