Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081107
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2004-04-07
Brief Title:
Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of KOS-862 Administered Intravenously Weekly for 3 Weeks Every 4 Weeks in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
Status:
COMPLETED
Status Verified Date:
2013-06
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 in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy
PURPOSE This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of epothilone D in terms of confirmed objective response rate in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy
Secondary
Determine the safety of this drug in these patients
Determine the response duration in patients who achieve complete response or partial response time to tumor progression and survival in patients treated with this drug
Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment
Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients
OUTLINE This is a multicenter open-label study
Patients receive epothilone D IV over 90 minutes on days 1 8 and 15 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 33-85 patients will be accrued for this study
Primary
Determine the antitumor activity of epothilone D in terms of confirmed objective response rate in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy
Secondary
Determine the safety of this drug in these patients
Determine the response duration in patients who achieve complete response or partial response time to tumor progression and survival in patients treated with this drug
Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment
Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients
OUTLINE This is a multicenter open-label study
Patients receive epothilone D IV over 90 minutes on days 1 8 and 15 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 33-85 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 |
|---|---|---|---|
| KOS-201 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000358910 | REGISTRY | None | None |
| ROCHE-N017352 | None | None | None |