Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087035
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2004-07-08
Brief Title:
Docetaxel and Erlotinib in Treating Older Patients With Prostate Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GENENTECH-OSI-2527S | None | None | None |
| UCLA-0308082 | None | None | None |
| AVENTIS-GIA-16115 | None | None | None |