Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293371
Status:
TERMINATED
Last Update Posted:
2012-10-11
First Post:
2006-02-16
Brief Title:
Docetaxel Prednisone and Vatalanib in Treating Patients With Advanced Prostate Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase III Study of DocetaxelPrednisone and PTK 787ZK 222584 in Previously Untreated Metastatic Hormone Refractory Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 and prednisone work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Giving vatalanib together with docetaxel and prednisone may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of vatalanib when given together with docetaxel and prednisone and to see how well they work in treating patients with advanced prostate cancer
PURPOSE This phase III trial is studying the side effects and best dose of vatalanib when given together with docetaxel and prednisone and to see how well they work in treating patients with advanced prostate cancer
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicities and maximum tolerated dose of vatalanib when used in combination with docetaxel and prednisone in patients with chemotherapy-naive metastatic hormone-refractory prostate cancer phase I
Secondary
Determine alterations in pharmacokinetics of docetaxel and vatalanib in these patients phase I
Determine the clinical efficacy of this regimen as measured by declines in prostate-specific antigen measurable disease response time to progression and overall survival phase II
OUTLINE This is a phase I open-label dose-escalation study of vatalanib followed by a phase II study
Phase I Patients receive docetaxel IV over 1 hour on day 2 Patients also receive oral prednisone twice daily and oral vatalanib once daily on days 1-21 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of vatalanib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
NOTE Vatalanib is administered on days 5-21 during the first course only
Phase II Patients receive prednisone docetaxel and vatalanib at the MTD as in phase I Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 93 patients will be accrued for this study
Primary
Determine the dose-limiting toxicities and maximum tolerated dose of vatalanib when used in combination with docetaxel and prednisone in patients with chemotherapy-naive metastatic hormone-refractory prostate cancer phase I
Secondary
Determine alterations in pharmacokinetics of docetaxel and vatalanib in these patients phase I
Determine the clinical efficacy of this regimen as measured by declines in prostate-specific antigen measurable disease response time to progression and overall survival phase II
OUTLINE This is a phase I open-label dose-escalation study of vatalanib followed by a phase II study
Phase I Patients receive docetaxel IV over 1 hour on day 2 Patients also receive oral prednisone twice daily and oral vatalanib once daily on days 1-21 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of vatalanib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
NOTE Vatalanib is administered on days 5-21 during the first course only
Phase II Patients receive prednisone docetaxel and vatalanib at the MTD as in phase I Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 93 patients 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 |
|---|---|---|---|
| UCSF-04557 | None | None | None |