Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225420
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2005-09-21
Brief Title:
Docetaxel Androgen Ablation and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
A Phase III Study of Concurrent Weekly Docetaxel Taxotere Androgen Ablation and Adaptive External Beam Radiotherapy for Localized High-Risk Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2017-04
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:
NRR
Brief Summary:
RATIONALE Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Androgens can cause the growth of prostate cancer cells Antihormone therapy such as leuprolide may lessen the amount of androgens made by the body Radiation therapy uses high energy x-rays to kill tumor cells Giving docetaxel together with androgen ablation therapy and external-beam radiation therapy may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of docetaxel when given together with androgen ablation therapy and external-beam radiation therapy and to see how well they work in treating patients with high-risk localized prostate cancer
PURPOSE This phase III trial is studying the side effects and best dose of docetaxel when given together with androgen ablation therapy and external-beam radiation therapy and to see how well they work in treating patients with high-risk localized prostate cancer
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of docetaxel when administered in combination with androgen ablation therapy and adaptive external-beam radiotherapy in patients with high-risk localized adenocarcinoma of the prostate
Secondary
Determine the 2-year biochemical progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter open-label dose-escalation study of docetaxel
Androgen ablation therapy Patients receive leuprolide acetate or other luteinizing hormone-releasing hormone agonist beginning 2-3 months prior to the start of chemoradiotherapy and continuing for up to 2 years
Chemoradiotherapy Patients receive docetaxel IV over 1 hour on day 1 and high-dose external-beam radiotherapy on days 1-5 Treatment repeats every 7 days for 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed every 3 months
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of docetaxel when administered in combination with androgen ablation therapy and adaptive external-beam radiotherapy in patients with high-risk localized adenocarcinoma of the prostate
Secondary
Determine the 2-year biochemical progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter open-label dose-escalation study of docetaxel
Androgen ablation therapy Patients receive leuprolide acetate or other luteinizing hormone-releasing hormone agonist beginning 2-3 months prior to the start of chemoradiotherapy and continuing for up to 2 years
Chemoradiotherapy Patients receive docetaxel IV over 1 hour on day 1 and high-dose external-beam radiotherapy on days 1-5 Treatment repeats every 7 days for 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed every 3 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