Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005857
Status:
COMPLETED
Last Update Posted:
2011-10-20
First Post:
2000-06-02
Brief Title:
Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Randomized Phase II Trial of Herceptin NSC 688097 and Weekly Docetaxel NSC 628503 in Androgen-Independent Horomone Refractory Adenocarcinoma of the Prostate CaP
Status:
COMPLETED
Status Verified Date:
2011-10
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 Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to compare the effectiveness of trastuzumab alone and in combination with docetaxel in treating patients who have metastatic prostate cancer that is refractory to hormone therapy
PURPOSE Phase II trial to compare the effectiveness of trastuzumab alone and in combination with docetaxel in treating patients who have metastatic prostate cancer that is refractory to hormone therapy
Detailed Description:
OBJECTIVES
Compare the efficacy and toxicity of docetaxel arm I vs trastuzumab Herceptin arm II followed by a combination of docetaxel and trastuzumab in patients with androgen-independent or hormone-refractory metastatic Her2neu-positive prostate cancer Arm I closed to accrual effective 07302001
OUTLINE This is a multicenter study
Arm I Patients receive docetaxel IV over 1 hour weekly for 6 weeks Treatment continues every 8 weeks for at least 2 courses in the absence of unacceptable toxicity Arm I closed to accrual effective 07302001 Arm I patients crossover to arm II
Arm II Patients receive trastuzumab Herceptin IV over 30-90 minutes weekly for 8 weeks Treatment continues every 8 weeks for at least 2 courses in the absence of unacceptable toxicity
Patients with progressive or stable disease after 2 courses of single-agent therapy receive docetaxel IV over 1 hour on day 1 of each week for 6 consecutive weeks and trastuzumab IV over 30-90 minutes on day 1 of each week for 8 consecutive weeks Treatment continues every 8 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients with complete or partial response to single-agent therapy continue on that therapy until experiencing progressive or stable disease The patients then proceed to combination therapy
Patients are followed until death
PROJECTED ACCRUAL A total of 108-160 patients 54-80 per treatment arm will be accrued for this study Arm I closed to accrual effective 07302001
Compare the efficacy and toxicity of docetaxel arm I vs trastuzumab Herceptin arm II followed by a combination of docetaxel and trastuzumab in patients with androgen-independent or hormone-refractory metastatic Her2neu-positive prostate cancer Arm I closed to accrual effective 07302001
OUTLINE This is a multicenter study
Arm I Patients receive docetaxel IV over 1 hour weekly for 6 weeks Treatment continues every 8 weeks for at least 2 courses in the absence of unacceptable toxicity Arm I closed to accrual effective 07302001 Arm I patients crossover to arm II
Arm II Patients receive trastuzumab Herceptin IV over 30-90 minutes weekly for 8 weeks Treatment continues every 8 weeks for at least 2 courses in the absence of unacceptable toxicity
Patients with progressive or stable disease after 2 courses of single-agent therapy receive docetaxel IV over 1 hour on day 1 of each week for 6 consecutive weeks and trastuzumab IV over 30-90 minutes on day 1 of each week for 8 consecutive weeks Treatment continues every 8 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
Patients with complete or partial response to single-agent therapy continue on that therapy until experiencing progressive or stable disease The patients then proceed to combination therapy
Patients are followed until death
PROJECTED ACCRUAL A total of 108-160 patients 54-80 per treatment arm will be accrued for this study Arm I closed to accrual effective 07302001
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 |
|---|---|---|---|
| CDR0000067884 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| U01CA063265 | NIH | None | None |
| P30CA033572 | NIH | None | None |
| CHNMC-PHII-19 | None | None | None |
| CHNMC-IRB-99118 | None | None | None |
| NCI-T98-0090 | None | None | None |