Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer
This is an open-label, single-arm Phase II study of dose-dense regimen with paclitaxel and
cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable
stage II, IIA NSCLC.
Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose
of 175mg/m2 on Day 1 of each 14-day cycle. Cisplatin 75mg/m2 will be given via intravenous
infusion on day 1 (after paclitaxel) according to institutional guidelines.
Pegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single
subcutaneous injection on Day 2 of each study cycle.
All drugs will be given in 2-weekly cycle. Three cycles of pre-operative chemotherapy are
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the evaluation of the clinical response rate of neo-adjuvant chemotherapy with dose-dense therapy of paclitaxel and cisplatin(PC) with peg-filgrastim in patients with operable NSCLC
Maciej Krzakowski, MD
M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw
Austria: Federal Ministry for Health and Women