NCT00094861

Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy Followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).

Detailed description

During the acute dysphagia evaluation phase (the period lasting from the administration of the first dose of investigational product through Week 12 (or up to Week 16 if dysphagia is not resolved to CTCAE v3.0 grade ≤ 1 by Week 12) participants underwent acute dysphagia assessments twice weekly. All participants were followed for disease progression, second primary tumors, other malignancies, and overall survival until death or loss to follow-up during the long term follow-up (still ongoing).

Conditions

• Dysphagia
• Non-Small Cell Lung Cancer
• Lung Cancer

Interventions

Type	Name	Description
DRUG	Palifermin
DRUG	Placebo
RADIATION	Radiotherapy
DRUG	Paclitaxel
DRUG	Carboplatin

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-12-01
• Completion: 2014-01-01
• First posted: 2004-10-27
• Last updated: 2017-03-14
• Results posted: 2014-03-06