Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182689
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2005-09-15
Brief Title:
Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of BAY 43-9006 NSC-724772 in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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 phase II trial is studying how well sorafenib works in treating patients with extensive stage small cell lung cancer Sorafenib may stop the growth of small cell lung cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the efficacy of BAY 43-0006 in previously-treated platinum-sensitive and platinum-refractory patients with measurable disease and extensive stage small cell lung cancer E-SCLC in terms of response rate confirmed and unconfirmed complete and partial
SECONDARY OBJECTIVES
I To assess the qualitative and quantitative toxicities of BAY 43-9006 in this patient population
II To assess overall survival in this group of patients treated with BAY 43-9006
III To collect specimens via the Lung Cancer Specimen Repository Protocol S9925 in order to perform exploratory analyses of the relationship between selected markers and patient outcomes
OUTLINE This is a multicenter study Patients are stratified according to platinum sensitivity status platinum sensitive vs platinum refractory
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for up to 2 years from study entry
I To evaluate the efficacy of BAY 43-0006 in previously-treated platinum-sensitive and platinum-refractory patients with measurable disease and extensive stage small cell lung cancer E-SCLC in terms of response rate confirmed and unconfirmed complete and partial
SECONDARY OBJECTIVES
I To assess the qualitative and quantitative toxicities of BAY 43-9006 in this patient population
II To assess overall survival in this group of patients treated with BAY 43-9006
III To collect specimens via the Lung Cancer Specimen Repository Protocol S9925 in order to perform exploratory analyses of the relationship between selected markers and patient outcomes
OUTLINE This is a multicenter study Patients are stratified according to platinum sensitivity status platinum sensitive vs platinum refractory
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for up to 2 years from study entry
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 |
|---|---|---|---|
| S0435 | OTHER | CTEP | httpsreporternihgovquickSearchU10CA032102 |
| NCI-2012-03074 | REGISTRY | None | None |
| U10CA032102 | NIH | None | None |
| S0435 | OTHER | None | None |