A Phase III, Randomized, Study of Weekly Taxoprexin Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
This is a randomized, multicenter, Phase III open-label study of weekly Taxoprexin® in
combination with every three (3) week carboplatin compared to paclitaxel plus carboplatin
every three (3) weeks, in patients with advanced non-small cell lung cancer (NSCLC) who have
not received cytotoxic agents for advanced disease. Patients may have been previously
treated with immunological agents. Patients will be randomized to receive Taxoprexin® at a
dose of 400 mg/m2 intravenously by one (1)-hour weekly infusion, 5/6 weeks followed
immediately by carboplatin AUC = 4 on weeks one (1) and four (4) as a 30 minute intravenous
infusion or paclitaxel 225mg/m2 as a three (3) hour intravenous infusion followed
immediately by carboplatin AUC = 6 as a 30 minute intravenous infusion, every three (3)
weeks. Patients will receive Taxoprexin® and carboplatin infusions or paclitaxel and
carboplatin infusions until progression of disease, intolerable toxicity, completion of six
(6) treatment cycles of paclitaxel plus carboplatin or three (3) treatment cycles of
Taxoprexin® plus carboplatin, refusal of continued treatment by the patient, or Investigator
decision.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival after 380 deaths
Robert Bellet, MD
Study Director
Luitpold Pharmaceuticals
United States: Food and Drug Administration
P01-04-20
NCT00243867
November 2005
April 2008
Name | Location |
---|---|
US Oncology | Houston, Texas 77060 |