NCT01969955

Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer

A Phase II Trial of Nab-paclitaxel as Second-line Therapy in Locally Advanced or Metastatic Squamous Lung Cancer After Failure of Platinum Doublet (Except Pemetrexed) Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer.

Detailed description

Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel, solvent-free, albumin-bound nanoparticle form of paclitaxel designed to avoid problems associated with solvents used in Taxol. And albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy, and with greater concentration in tumor tissue compared with normal tissues. A multicenter randomized controled trial (coded as CA031) showed that nab-paclitaxel in combination with carboplatin had higher response rate than traditional paclitaxel plus carboplatin, especially in squamous lung cancer. This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of nab-paclitaxel monotherapy in previously treated advanced or metastatic squamous lung cancer after failure of platinum-based doublet therapy.

Conditions

• Squamous Cell Carcinoma of Lung

Interventions

Type	Name	Description
DRUG	nanoparticle albumin-bound paclitaxel	Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2013-10-25
• Last updated: 2014-04-25

Locations

1 site across 1 country: China