Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453167
Status:
COMPLETED
Last Update Posted:
2010-07-12
First Post:
2007-03-27
Brief Title:
Weekly Paclitaxel Plus Gemcitabine as Second-line in Small Cell Lung Cancer
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
A Phase II Study of Weekly Paclitaxel and Gemcitabine as Second-line Therapy in Patients With Metastatic or Recurrence Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2010-07
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:
As a single agent paclitaxel has a response rate of 33 and 25-29 in SCLC patients with sensitive relapse and with resistant relapse respectively As a single agent gemcitabine also has a response rate 16 and 6-13 in SCLC patients with sensitive relapse and with resistant relapse respectively Because of single-agent activity different mechanism of action non-overlapping toxicities and beneficial pharmacologic interaction paclitaxel and gemcitabine combinations are attractive for testing in clinical trials
Detailed Description:
The treatment consists of paclitaxel 80 mgm2 and gemcitabine 1000 mgm2 given intravenously on days 1 and 8 of a 21-day cycle
Patients receive treatment every 3 weeks till disease progression
Patients receive treatment every 3 weeks till disease progression
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