NCT00473486

Study in Patients With Advanced Non-Small Cell Lung Cancer Treated With Pemetrexed and Carboplatin Plus or Minus Sorafenib

A Randomized (PhaseII), Double-blind, Multicenter Phase I/II Trial of Pemetrexed, Carboplatin Plus or Minus Sorafenib in the First-line Treatment of Patients With Stage IIIb or IV Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The majority of patients with advanced NSCLC treated with standard platinum based chemotherapy regimens ultimately develop disease progression. Active therapies with improved toxicity profiles are clearly needed in this setting. The primary objective of this trial is to assess the toxicity profile and to determine the effect on progression free survival and time to progression in patients with advanced NSCLC treated with sorafenib in addition to carboplatin and pemetrexed.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	pemetrexed, carboplatin, sorafenib	Ph. 1: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1; Sorafenib 200mg po bid days 2-19; 400mg po bid days 2-19 Ph 2: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1;sorafenib depending on results of Ph 1
DRUG	pemetrexed, carboplatin, placebo	Ph 2: pemetrexed 500mg/m² iv day 1; carboplatin AUC 6 iv day 1; placebo day 2-19

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-08-01
• Completion: 2010-01-01
• First posted: 2007-05-15
• Last updated: 2010-01-27

Locations

1 site across 1 country: Germany