drugset / Trial / NCT00425191

Taxotere Combinations as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.

NCT00425191 ↗

Phase 2 Completed 165 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

To assess the antitumour activity (response rate) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of cisplatin /gemcitabine followed by docetaxel as first line chemotherapy · To evaluate the quantitative and qualitative toxicity of each treatment arms.· To determine time to progression, duration of response, time to treatment failure, and overall survival in each group.· To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm.

Timeline

Start
2002-07
Primary completion
2005-04
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Docetaxel Small molecule 40 mg/m2 Intravenous
Subject Docetaxel Small molecule 50 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1200 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1600 mg/m2 Intravenous