Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077259
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2004-02-10
Brief Title:
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study Of KOS-862 Epothilone D Administered Intravenously Weekly For 3 Weeks Every 4 Weeks In The Second-Line Treatment Of Patients With Advanced Or Metastatic Colorectal Carcinoma CRC
Status:
COMPLETED
Status Verified Date:
2013-01
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 Drugs used in chemotherapy such as epothilone D work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well epothilone D works as second-line therapy in treating patients with advanced or metastatic refractory colorectal cancer
PURPOSE This phase II trial is studying how well epothilone D works as second-line therapy in treating patients with advanced or metastatic refractory colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of epothilone D as second-line treatment in terms of objective response rate in patients with advanced or metastatic refractory colorectal cancer
Secondary
Determine the safety of this drug in these patients
Determine the response duration in patients responding to treatment with this drug
Determine time to tumor progression and overall survival in patients treated with this drug
Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients
OUTLINE This is an open-label multicenter study
Patients receive epothilone D IV over 90 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 19-69 patients will be accrued for this study
Primary
Determine the antitumor activity of epothilone D as second-line treatment in terms of objective response rate in patients with advanced or metastatic refractory colorectal cancer
Secondary
Determine the safety of this drug in these patients
Determine the response duration in patients responding to treatment with this drug
Determine time to tumor progression and overall survival in patients treated with this drug
Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients
OUTLINE This is an open-label multicenter study
Patients receive epothilone D IV over 90 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 19-69 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ROCHE-NO17320 | None | None | None |
| MSKCC-03113 | None | None | None |