Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085228
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2004-06-10
Brief Title:
Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma Cancer of the Prostate
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase II Trial of Docetaxel Taxotere and Oblimersen Antisense Oligonucleotide Directed to BCL-2 Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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 Oblimersen may increase the effectiveness of docetaxel by making tumor cells more sensitive to the drug
PURPOSE This randomized phase II trial is studying how well giving docetaxel together with oblimersen works compared to docetaxel alone in treating patients with hormone-refractory adenocarcinoma cancer of the prostate
PURPOSE This randomized phase II trial is studying how well giving docetaxel together with oblimersen works compared to docetaxel alone in treating patients with hormone-refractory adenocarcinoma cancer of the prostate
Detailed Description:
OBJECTIVES
Primary
Compare the activity of docetaxel with or without oblimersen in terms of prostate-specific antigen response in patients with hormone-refractory adenocarcinoma of the prostate
Compare the toxicity of these regimens in these patients
Secondary
Compare the time to progression in patients treated with these regimens
Compare survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center metastatic disease M0 vs M1 with non-measurable lesions only vs M1 with measurable lesions prior estramustine yes vs no and prior bisphosphonates yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 5 and oblimersen IV continuously on days 1-7
Arm II Patients receive docetaxel IV over 1 hour on day 1 In both arms treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until progressive disease and then every 16 weeks thereafter
PROJECTED ACCRUAL A total of 102 patients 51 per treatment arm will be accrued for this study
Primary
Compare the activity of docetaxel with or without oblimersen in terms of prostate-specific antigen response in patients with hormone-refractory adenocarcinoma of the prostate
Compare the toxicity of these regimens in these patients
Secondary
Compare the time to progression in patients treated with these regimens
Compare survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center metastatic disease M0 vs M1 with non-measurable lesions only vs M1 with measurable lesions prior estramustine yes vs no and prior bisphosphonates yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 5 and oblimersen IV continuously on days 1-7
Arm II Patients receive docetaxel IV over 1 hour on day 1 In both arms treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until progressive disease and then every 16 weeks thereafter
PROJECTED ACCRUAL A total of 102 patients 51 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| AVENTIS-AVE3139E2501 | None | None | None |
| EORTC-30021 | None | None | None |