An Open-Label, Phase I/II 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
- 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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
Naiyer Rizvi, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|