Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416533
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2006-12-27
Brief Title:
Docetaxel Doxorubicin and Prednisone in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase II Study of Taxotere Docetaxel Plus Adriamycin Doxorubicin and Prednisone TAP in Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 doxorubicin and prednisone work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving docetaxel doxorubicin and prednisone together works in treating patients with advanced prostate cancer that has not responded to hormone therapy
PURPOSE This phase II trial is studying how well giving docetaxel doxorubicin and prednisone together works in treating patients with advanced prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Primary
Assess prostate specific antigen response rate to docetaxel doxorubicin hydrochloride and prednisone in patients with hormone-refractory advanced prostate cancer
Secondary
Assess if treatment with docetaxel doxorubicin hydrochloride and prednisone will improve health-related quality of life of these patients
Assess the toxicity of docetaxel doxorubicin hydrochloride and prednisone
Assess response rate in measurable disease
OUTLINE Patients receive docetaxel IV over 1 hour on day 1 doxorubicin hydrochloride IV over 15 minutes on days 1 and 8 and oral prednisone once daily on days 1-21 Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on day 1 of each course after completion of 3 courses and at disease progression
After completing study treatment patients are followed every 6 months for 1 year
PROJECTED ACCRUAL A total of 47 patients will be accrued for this study
Primary
Assess prostate specific antigen response rate to docetaxel doxorubicin hydrochloride and prednisone in patients with hormone-refractory advanced prostate cancer
Secondary
Assess if treatment with docetaxel doxorubicin hydrochloride and prednisone will improve health-related quality of life of these patients
Assess the toxicity of docetaxel doxorubicin hydrochloride and prednisone
Assess response rate in measurable disease
OUTLINE Patients receive docetaxel IV over 1 hour on day 1 doxorubicin hydrochloride IV over 15 minutes on days 1 and 8 and oral prednisone once daily on days 1-21 Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on day 1 of each course after completion of 3 courses and at disease progression
After completing study treatment patients are followed every 6 months for 1 year
PROJECTED ACCRUAL A total of 47 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AVENTIS-CCCWFU-85302 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000466318 | REGISTRY | None | None |
| CCCWFU-BG04-264 | None | None | None |