Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005091
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2000-04-06
Brief Title:
DX-8951f in Treating Previously Untreated Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Sponsor:
Daiichi Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer as First Line Therapy
Status:
COMPLETED
Status Verified Date:
2008-01
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of DX-8951f in treating patients who have previously untreated stage IIIB or stage IV non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of DX-8951f in treating patients who have previously untreated stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the antitumor activity of DX-8951f in previously untreated patients with stage IIIB or IV non-small cell lung cancer II Evaluate the quantitative and qualitative toxic effects of this regimen in these patients III Evaluate the pharmacokinetics of this regimen in these patients IV Assess the time to progression and survival status of these patients
OUTLINE This is a multicenter study Patients receive DX-8951f IV over 30 minutes daily for 5 days Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for survival
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive DX-8951f IV over 30 minutes daily for 5 days Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for survival
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-99044 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067724 | REGISTRY | None | None |