ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00077246
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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 I/II 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 1.5 years.
PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007 Objective target lesion response (complete or partial) as measured by RECIST criteria
- Secondary Outcome Measures
Name Time Method Nadir of myelosuppression Changes in physical examination Changes in hematologic and clinical chemistry values Percentage of patients with complete or partial target response (total response) Duration of response Incidence of treatment-emergent adverse events and serious adverse events Percentage of patients with stable disease for ≥ 16 weeks Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment Time to disease progression Survival
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States