A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.
Patients with stage IV NSCLC and measurable disease are included in a randomized phase II
trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine
doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent
cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2
d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and
paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with
dose decrease if needed). Response criteria are assessed with RECIST classification by the
investigator panel.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
1-Complete response
Alain Vergnengre, MD
Principal Investigator
University Hospital, Limoges
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
I03022
NCT00199758
September 2003
June 2007
Name | Location |
---|