Finding studies
Finding studies
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Lead
Memorial Sloan Kettering Cancer Center
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
