Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00291850|
Recruitment Status : Terminated (no patient recruitment)
First Posted : February 15, 2006
Last Update Posted : May 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Paclitaxel, Cisplatin, Pegfilgrastim||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2005|
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291850
|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|