Randomized Phase II Study to Determine the Efficacy of a Three Weekly vs. Weekly Therapy With Paclitaxel Plus Carboplatin vs. Paclitaxel Plus Vinorelbine for Patients With Non Small Cell Lung Cancer According to UICC Stage IIIB and IV
Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined
chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with
Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing
intervals, which will be assessed as well (4 Arm study).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of response rate (stable disease [SD] or better)
Ulrich Keilholz, MD
Principal Investigator
Charité Campus Benjamin Franklin
Germany: Federal Institute for Drugs and Medical Devices
Haema CBF NSCLC UK/AS 03
NCT00168883
October 2002
December 2006
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