Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118092
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2005-07-08
Brief Title:
17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of 17-Allylamino-17-Demethoxygeldanamycin 17-AAG in Patients With Hormone-Refractory Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-03
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:
This phase II trial is studying how well 17-AAG works in treating patients with metastatic prostate cancer that did not respond to previous hormone therapy Drugs used in chemotherapy such as 17-AAG work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I Determine the prostate-specific antigen PSA response in patients with hormone-refractory metastatic prostate cancer treated with 17-N-allylamino-17-demethoxygeldanamycin 17-AAG
SECONDARY OBJECTIVES
I Determine the overall survival and disease-free survival rate in patients treated with this drug
II Determine the safety profile of this drug in these patients III Determine the duration of PSA response and PSA control in patients treated with this drug
IV Determine the partial and complete response rates in patients with measurable disease treated with this drug
V Correlate changes in expression levels of interleukin-6 maspin and NF-kappaB in serum and tissue with cancer and treatment-related outcomes in patients treated with this drug
OUTLINE This is a multicenter study Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 2-6 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 2 additional courses of treatment beyond documentation of CR
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 16-28 patients will be accrued for this study within 20 months
I Determine the prostate-specific antigen PSA response in patients with hormone-refractory metastatic prostate cancer treated with 17-N-allylamino-17-demethoxygeldanamycin 17-AAG
SECONDARY OBJECTIVES
I Determine the overall survival and disease-free survival rate in patients treated with this drug
II Determine the safety profile of this drug in these patients III Determine the duration of PSA response and PSA control in patients treated with this drug
IV Determine the partial and complete response rates in patients with measurable disease treated with this drug
V Correlate changes in expression levels of interleukin-6 maspin and NF-kappaB in serum and tissue with cancer and treatment-related outcomes in patients treated with this drug
OUTLINE This is a multicenter study Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 2-6 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 2 additional courses of treatment beyond documentation of CR
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 16-28 patients will be accrued for this study within 20 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 |
|---|---|---|---|
| N01CM62205 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62205 |
| NCI-6651 | None | None | None |
| NCI-2012-01466 | REGISTRY | None | None |
| CDR0000433492 | None | None | None |
| MAYO-MC0453 | None | None | None |
| MC0453 | OTHER | None | None |
| 6651 | OTHER | None | None |