Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005960
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Amgen
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Doxorubicin and Cyclophosphamide With Sequential Docetaxel in Patients With Hormone-Refractory Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2001-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Determine the PSA response duration of PSA response disease free survival median survival and overall survival in patients with chemotherapy naive hormone refractory adenocarcinoma of the prostate treated with doxorubicin and cyclophosphamide with sequential docetaxel II Assess for any improvement in pain over time in patients treated with this regimen
OUTLINE This is a multicenter study Patients receive doxorubicin IV over 3-5 minutes and cyclophosphamide IV on days 1 22 43 and 64 and docetaxel IV over 1 hour on days 85 106 and 127 in the absence of disease progression or unacceptable toxicity Patients receive filgrastim G-CSF subcutaneously daily beginning 24 hours after completion of chemotherapy infusions and continuing until blood counts recover G-CSF must be discontinued at least 24 hours prior to starting subsequent chemotherapy infusions Pain and analgesic use are assessed before study every 3 weeks during study after completion of study and then at 3 months after completion of study Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter until death
PROJECTED ACCRUAL Approximately 42-105 patients will be accrued for this study over 18 months
OUTLINE This is a multicenter study Patients receive doxorubicin IV over 3-5 minutes and cyclophosphamide IV on days 1 22 43 and 64 and docetaxel IV over 1 hour on days 85 106 and 127 in the absence of disease progression or unacceptable toxicity Patients receive filgrastim G-CSF subcutaneously daily beginning 24 hours after completion of chemotherapy infusions and continuing until blood counts recover G-CSF must be discontinued at least 24 hours prior to starting subsequent chemotherapy infusions Pain and analgesic use are assessed before study every 3 weeks during study after completion of study and then at 3 months after completion of study Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter until death
PROJECTED ACCRUAL Approximately 42-105 patients will be accrued for this study over 18 months
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 |
|---|---|---|---|
| AMGEN-GCSF-980282 | None | None | None |
| NCI-V00-1595 | None | None | None |