Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020046
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2007-03-02
Brief Title:
Docetaxel With or Without Thalidomide in Treating Patients With Metastatic Prostate Cancer
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Randomized Study of Docetaxel With or Without Thalidomide in Patients With Androgen-Independent Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-03
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 use different ways to stop tumor cells from dividing so they stop growing or die Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor
PURPOSE Randomized phase II trial to compare the effectiveness of docetaxel with or without thalidomide in treating patients who have metastatic prostate cancer
PURPOSE Randomized phase II trial to compare the effectiveness of docetaxel with or without thalidomide in treating patients who have metastatic prostate cancer
Detailed Description:
OBJECTIVES I Determine the efficacy of thalidomide with docetaxel in terms of clinical response in patients with androgen-independent metastatic prostate cancer
II Compare the pharmacokinetics of docetaxel with or without thalidomide in these patients III Determine whether any pharmacodynamic relationships exist between plasma concentrations and clinical activity or toxicity of these regimens in this patient population
IV Compare changes in molecular markers of angiogenesis and markers of apoptosis after treatment with these regimens in these patients
PROTOCOL OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients receive docetaxel IV over 30 minutes once weekly for 3 weeks Arm II Patients receive oral thalidomide daily beginning on day 2 and docetaxel IV over 30 minutes on days 2 9 and 16
Treatment continues every 28 days in both arms in the absence of unacceptable toxicity or disease progression
Patients are followed every 2 months
PROJECTED ACCRUAL
A total of 75 patients 25 to arm I and 50 to arm II will be accrued for this study within 18 months
II Compare the pharmacokinetics of docetaxel with or without thalidomide in these patients III Determine whether any pharmacodynamic relationships exist between plasma concentrations and clinical activity or toxicity of these regimens in this patient population
IV Compare changes in molecular markers of angiogenesis and markers of apoptosis after treatment with these regimens in these patients
PROTOCOL OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients receive docetaxel IV over 30 minutes once weekly for 3 weeks Arm II Patients receive oral thalidomide daily beginning on day 2 and docetaxel IV over 30 minutes on days 2 9 and 16
Treatment continues every 28 days in both arms in the absence of unacceptable toxicity or disease progression
Patients are followed every 2 months
PROJECTED ACCRUAL
A total of 75 patients 25 to arm I and 50 to arm II will be accrued for this study within 18 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 |
|---|---|---|---|
| CDR0000067602 | None | None | None |
| 00-C-0033 | None | None | None |