Conditions: Non-small Cell Lung Cancer (NSCLC)
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL intervention 2: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
Intervention descriptions: intervention 1: On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles. intervention 2: After all participants in Dose Level 1 (ixabepilone, 32 mg/m\^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m\^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.

Protocol document: