Ignite Creation Date:
2025-12-18 @ 6:48 AM
Ignite Modification Date:
2025-12-23 @ 9:50 PM
Study NCT ID:
NCT00748163
Status:
None
Last Update Posted:
2018-08-08 00:00:00
First Post:
2008-09-05 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Sunitinib as First-Line Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
Phase II Study of ABI-007 Plus Sunitinib as First Line Treatment for Non-Small Cell Lung Cancer
Status:
None
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study has been abandoned for lack of available funding.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES:
Primary
* To determine the tumor response rate in patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.
Secondary
* To determine the time to objective tumor response and duration of response in responding patients.
* To determine the time to treatment failure and overall survival of these patients.
* To characterize the toxicities of this regimen in these patients.
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients also receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 8 weeks until disease progression and then every 3 months for up to 1 year.
Primary
* To determine the tumor response rate in patients with stage IV non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle formulation and sunitinib malate as first-line therapy.
Secondary
* To determine the time to objective tumor response and duration of response in responding patients.
* To determine the time to treatment failure and overall survival of these patients.
* To characterize the toxicities of this regimen in these patients.
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients also receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 8 weeks until disease progression and then every 3 months for up to 1 year.
Detailed Description:
None
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?: