Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077246
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2004-02-10
Brief Title:
ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Label Phase III Trial Of ABI-007 A CREMOPHOR El-Free Protein Stabilized Nanoparticle Paclitaxel Administered Weekly In Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2009-12
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:
RATIONALE Drugs used in chemotherapy such as ABI-007 work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase III trial is studying the side effects and best dose of ABI-007 and to see how well it works in treating patients with stage IV non-small cell lung cancer
PURPOSE This phase III trial is studying the side effects and best dose of ABI-007 and to see how well it works in treating patients with stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of paclitaxel albumin-stabilized Nanoparticle formulation ABI-007 in patients with chemotherapy-naïve stage IV non-small cell lung cancer
Determine the antitumor activity of this drug in these patients
Determine the safety and tolerability of this drug in these patients
Secondary
Determine the time to disease progression in patients treated with this drug
Determine duration of response in patients treated with this drug
Determine survival of patients treated with this drug
OUTLINE This is an open-label dose-escalation study
Phase I Patients receive paclitaxel albumin-stabilized Nanoparticle formulation ABI-007 IV on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ABI-007 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive ABI-007 as above at the MTD determined in phase I Patients are followed monthly for 6 months and then every 3 months for 15 years
PROJECTED ACCRUAL A total of 64 patients will be accrued for this study
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of paclitaxel albumin-stabilized Nanoparticle formulation ABI-007 in patients with chemotherapy-naïve stage IV non-small cell lung cancer
Determine the antitumor activity of this drug in these patients
Determine the safety and tolerability of this drug in these patients
Secondary
Determine the time to disease progression in patients treated with this drug
Determine duration of response in patients treated with this drug
Determine survival of patients treated with this drug
OUTLINE This is an open-label dose-escalation study
Phase I Patients receive paclitaxel albumin-stabilized Nanoparticle formulation ABI-007 IV on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ABI-007 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive ABI-007 as above at the MTD determined in phase I Patients are followed monthly for 6 months and then every 3 months for 15 years
PROJECTED ACCRUAL A total of 64 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ABI-CA015 | None | None | None |
| MSKCC-03111 | None | None | None |