Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294190
Status:
COMPLETED
Last Update Posted:
2012-12-10
First Post:
2006-02-16
Brief Title:
Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2011-05
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:
This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity To help ameliorate the fatigue planned rest weeks will be incorporated into the schedule This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC
Detailed Description:
All patients will receive weekly topotecan
Topotecan 6mgm2 IV weekly x 6 consecutive weeks followed by a 2 week break Cycles are repeated every 8 weeks for 3 cycles Restaging studies will be performed every cycle or 8 weeks
Topotecan 6mgm2 IV weekly x 6 consecutive weeks followed by a 2 week break Cycles are repeated every 8 weeks for 3 cycles Restaging studies will be performed every cycle or 8 weeks
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 |
|---|---|---|---|
| 105642 | None | None | None |