Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415779
Status:
COMPLETED
Last Update Posted:
2010-02-24
First Post:
2006-12-22
Brief Title:
ZANTE Zometa and Taxotere in Hormone Refractory Prostate Cancer
Sponsor:
National Cancer Institute Naples
Organization:
National Cancer Institute Naples
Study Overview
Official Title:
Phase I Study of the Combination of Zoledronic Acid and Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2010-02
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:
ZANTE
Brief Summary:
This phase I trial is studying the side effects and best dose of docetaxel when given with zoledronic acid in patients with bone metastasis from prostate cancer that has not responded to hormone therapy
Detailed Description:
Docetaxel has been used alone and in combination with other anti-cancer therapies in the treatment of hormone refractory metastatic prostate cancer Zoledronic acid has been used in the treatment of bone metastasis from prostate cancer This is a study of the combination of these two agents The Zante study will test a dose escalation of docetaxel in association with a predetermined dose of zoledronic acid 2 mg given every 14 days for a minimum of 6 and maximum of 12 cycles
Sequence A Docetaxel on day 1 and zoledronic acid on day 2
Sequence B Zoledronic acid on day 1 and docetaxel on day 2
Patients are enrolled sequentially in cohorts of 3 for each dose level and a maximum of 36 patients will be enrolled
Sequence A Docetaxel on day 1 and zoledronic acid on day 2
Sequence B Zoledronic acid on day 1 and docetaxel on day 2
Patients are enrolled sequentially in cohorts of 3 for each dose level and a maximum of 36 patients will be enrolled
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 |
|---|---|---|---|
| EUDRACT 2006-000426-31 | None | None | None |