Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215345
Status:
UNKNOWN
Last Update Posted:
2005-09-22
First Post:
2005-09-20
Brief Title:
A Phase II Trial of Combination Therapy With Celecoxib and Taxotere for the Treatment of Stage D3 Prostate Cancer
Sponsor:
Department of Veterans Affairs New Jersey
Organization:
Department of Veterans Affairs New Jersey
Study Overview
Official Title:
A Phase II Trial of Combination Therapy With Celecoxib and Taxotere for the Treatment of Stage D3 Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to find out the safety and effectiveness as well as patients quality of life on the combination of Taxotere and celecoxib on patients with hormone refractory prostate cancer Celecoxib Celebrex is an FDA approved drug to treat arthritis Taxotere Docetaxel is an FDA approved chemotherapy drug to treat certain forms of cancer Both drugs have demonstrated evidences of tumor blood vessel suppression and combination of these two drugs could possibly arrest further tumor growth or make the tumor decrease in size
Detailed Description:
The standard hormone therapy for patients with metastases is androgen deprivation This treatment leads to response in 75-80 of the patients with median duration of response of only 14-18 months Once the patient becomes hormone resistant there is no effective therapy to prolong life For patients with HRPC the median life expectancy is 17 months2 Thus palliative care remains the standard therapy for HRPC The most widely used chemotherapy regimens are combinations of mitoxantrone with prednisone and taxanes with estramustine phosphate345 Taxotere has also demonstrated activity in prostate cancer cell lines6 Several clinical studies have demonstrated its activity in patients with metastatic prostate cancer as a single agent or in combination4 5 Taxotere may exert its effects in part through anti-angiogenic effects7 Recent work in animal models has provided additional evidence for the beneficial role of angiostatic agents in the treatment of malignant diseases This is the first study of the two drugs used together in prostate cancer
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 |
|---|---|---|---|
| GIA16125 | None | None | None |