Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315211
Status:
TERMINATED
Last Update Posted:
2018-08-20
First Post:
2006-04-17
Brief Title:
Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer
Sponsor:
Aultman Health Foundation
Organization:
Aultman Health Foundation
Study Overview
Official Title:
Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are
To determine the overall response rate of patients treated with at least 2 cycles of this regimen
To determine the feasibility and toxicity of the combination of topotecan and docetaxel
To determine the overall response rate of patients treated with at least 2 cycles of this regimen
To determine the feasibility and toxicity of the combination of topotecan and docetaxel
Detailed Description:
The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel The secondary objectives were to determine the feasibility and toxicities of this combination The final secondary objective is overall survival for patients that received 2 or more cycles
Methods Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment Pts received Docetaxel 30 mgm2 IV followed by Topotecan 3 mgm2 IV Days 1 and 8 of a 21 day cycle Disease assessment was done every 2 cycles Toxicity was measured each cycle
Methods Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment Pts received Docetaxel 30 mgm2 IV followed by Topotecan 3 mgm2 IV Days 1 and 8 of a 21 day cycle Disease assessment was done every 2 cycles Toxicity was measured each cycle
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 |
|---|---|---|---|
| Lung 01 | OTHER | Aultman Health Foundation | None |