Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337077
Status:
COMPLETED
Last Update Posted:
2014-06-23
First Post:
2006-06-13
Brief Title:
Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of E7389 Halichondrin B Analog in Patients With Metastatic Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2014-04
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 eribulin mesylate E7389 Halichondrin B Analog works in treating patients with metastatic prostate cancer that did not respond to hormone therapy Drugs used in chemotherapy such as eribulin mesylate 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 number of patients with a 50 decrease in prostate-specific antigen PSA of at least 4 weeks duration in patients with hormone-refractory metastatic prostate cancer treated with E7389 eribulin mesylate
SECONDARY OBJECTIVES
I Estimate the measurable disease response in patients with measurable disease
II Determine the duration of PSA and measurable disease response
III Characterize the safety and tolerability of E7389 in these patients
OUTLINE
This study enrolled 3 cohorts of patients based on the number of prior chemotherapy regimens received The 3 cohorts are chemonaive stratum prior-taxane stratum and two-prior-chemotherapy stratum Patients receive eribulin mesylate intravenously IV over 5 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 5 years
I Determine the number of patients with a 50 decrease in prostate-specific antigen PSA of at least 4 weeks duration in patients with hormone-refractory metastatic prostate cancer treated with E7389 eribulin mesylate
SECONDARY OBJECTIVES
I Estimate the measurable disease response in patients with measurable disease
II Determine the duration of PSA and measurable disease response
III Characterize the safety and tolerability of E7389 in these patients
OUTLINE
This study enrolled 3 cohorts of patients based on the number of prior chemotherapy regimens received The 3 cohorts are chemonaive stratum prior-taxane stratum and two-prior-chemotherapy stratum Patients receive eribulin mesylate intravenously IV over 5 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 5 years
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 |
|---|---|---|---|
| U10CA021115 | NIH | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2009-00566 | REGISTRY | None | None |
| E5805 | OTHER | None | None |