Conditions: Non-Small Cell Lung Carcinoma
Keywords: Advanced Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1052
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).

Detailed description:

Arms:
arm 1: Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m\^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg\*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. arm 2: Participants received 200 mg/m\^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg\*min/mL on Day 1 of a 21 day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.

Interventions: intervention 1: Albumin-bound paclitaxel intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: Administered by intravenous infusion. intervention 2: Administered by intravenous infusion. intervention 3: Administered by intravenous infusion. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate \[GFR\] + 25). For the purposes of this protocol, the GFR is considered to be equivalent to creatinine clearance (calculated by the method of Cockcroft and Gault, 1976).

Protocol document: