Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004924
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2000-03-07
Brief Title:
Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2009-08
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 Combining more than one drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving paclitaxel together with irinotecan works in treating patients with advanced non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving paclitaxel together with irinotecan works in treating patients with advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity and toxicities of irinotecan and paclitaxel in patients with advanced non-small cell lung cancer
OUTLINE Patients receive paclitaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes Treatment continues weekly for 2 weeks followed by one week of rest Courses are repeated every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year then every 6 months thereafter
PROJECTED ACCRUAL A total of 11-22 patients will be accrued for this study over 12 months
Determine the antitumor activity and toxicities of irinotecan and paclitaxel in patients with advanced non-small cell lung cancer
OUTLINE Patients receive paclitaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes Treatment continues weekly for 2 weeks followed by one week of rest Courses are repeated every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year then every 6 months thereafter
PROJECTED ACCRUAL A total of 11-22 patients will be accrued for this study over 12 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 |
|---|---|---|---|
| NCI-G00-1701 | None | None | None |
| YALE-HIC-10740 | None | None | None |