Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450008
Status:
TERMINATED
Last Update Posted:
2016-03-17
First Post:
2007-03-19
Brief Title:
Safety and Efficacy Study of GM-CSF Thalidomide Plus Docetaxel in Prostate Cancer
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Phase II Study of Patients With Hormone-Naïve Prostate Cancer With a Rising Prostate Specific Antigen Granulocyte-Macrophage Colony-Stimulating Factor GM-CSF Thalidomide Plus Docetaxel
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the relative efficacy and toxicity of combination therapy of GM-CSF Thalidomide plus Docetaxel in patients with prostate cancer with a rising PSA
Detailed Description:
As more men are being diagnosed and treated for prostate cancer at an early age the number who experiences a rising level of prostate-specific antigen PSA after initial treatment is increasing affecting approximately 50000 patients each year
These three drugs are commercially available Thalidomide is an angiogenesis inhibitor which blocks the development of new blood vessels GM-CSF stimulates the bodys immune response to fight cancer Docetaxel is the most active chemotherapeutic agent in the treatment of prostate cancer GM-CSF and thalidomide have proven activity in suppressing PSA values
This study design offers an opportunity to add cytotoxic therapy docetaxel in combination with an active pathobiologic regimen GM-CSF plus thalidomide to eradicate micrometastatic disease thus potentially offering a significant delay to clinical failure as measured by a rise in PSA or radiographic involvement Additionally delays in the use of hormone therapy has the potential to be of significant benefit
GM-CSF will be administered at a fixed dose 3 days per week by subcutaneous injection for 12 months Participants will receive a fixed dose of thalidomide orally at bedtime daily without interruption for 12 months Docetaxel will be administered intravenously over 1 hour on week 1 of every cycle every 3 weeks for 18 weeks
These three drugs are commercially available Thalidomide is an angiogenesis inhibitor which blocks the development of new blood vessels GM-CSF stimulates the bodys immune response to fight cancer Docetaxel is the most active chemotherapeutic agent in the treatment of prostate cancer GM-CSF and thalidomide have proven activity in suppressing PSA values
This study design offers an opportunity to add cytotoxic therapy docetaxel in combination with an active pathobiologic regimen GM-CSF plus thalidomide to eradicate micrometastatic disease thus potentially offering a significant delay to clinical failure as measured by a rise in PSA or radiographic involvement Additionally delays in the use of hormone therapy has the potential to be of significant benefit
GM-CSF will be administered at a fixed dose 3 days per week by subcutaneous injection for 12 months Participants will receive a fixed dose of thalidomide orally at bedtime daily without interruption for 12 months Docetaxel will be administered intravenously over 1 hour on week 1 of every cycle every 3 weeks for 18 weeks
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 |
|---|---|---|---|
| PCa-06-102 | OTHER | Principal Investigator | None |