NCT00540514

Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer

A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,052 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Albumin-bound paclitaxel	Administered by intravenous infusion.
DRUG	Paclitaxel	Administered by intravenous infusion.
DRUG	Carboplatin	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).

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-10-01
• Completion: 2013-02-01
• First posted: 2007-10-08
• Last updated: 2019-10-29
• Results posted: 2013-08-19

Locations

37 sites across 2 countries: United States, Canada