Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC
A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.
Non-Small Cell Lung Cancer
Drug: Paclitaxel, Cisplatin, Pegfilgrastim
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer|
- 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
- >To evaluate the safety of neo-adjuvant chemotherapy with PC
- - to characterize the toxicity of PC, include febrile neutropenia.
- - to evaluate peri- and post-operative mortality
- > to determine the pathological complete response rate
- > to determine the complete tumor resection rate
- > to evaluate proportion of cycle 2 and all cycles chemotherapy given with planned dose-on-time and proportion of patients receiving planned dose-on-time in cycle 2 and over all cycles.
- > To evaluate the following time-to-event efficacy variables:
- - disease free survival
- - overall survival
- > to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)
|Study Start Date:||June 2005|
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 planned.
|AKH, Universitätsklinik für Innere Medizin 1|
|Vienna, Austria, 1090|
|Somogy Country Pulmo and Cardio Hospital,|
|M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,|
|Warszawa, Poland, 02-781|
|Klinika Chirurgii Instytutu Gruzlicy i Chorob Pluc|
|Principal Investigator:||Maciej Krzakowski, MD||M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw|