Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC

This study has been terminated.
(no patient recruitment)
Information provided by (Responsible Party):
Central European Cooperative Oncology Group Identifier:
First received: February 14, 2006
Last updated: April 30, 2012
Last verified: April 2012

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.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Paclitaxel, Cisplatin, Pegfilgrastim
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Central European Cooperative Oncology Group:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • >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)

Enrollment: 50
Study Start Date: June 2005
Detailed Description:

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • histologic or cytologic diagnosis of NSCLC
  • Presence of clinical Stage IIA,IIB or IIA disease
  • tumor amenable to curative surgical resection
  • Patients with clinically measurable lesions will be enrolled in this study.
  • No prior tumor therapy
  • Performance status of 0-1 on ECOG Scale
  • Patients compliance and geographic proximity that allow adequate follow-up.
  • Medical fitness of patient, including respiratory function, adequate for radical NSCLC surgery.

Exclusion Criteria:

  • Presence of clinical Stage IIIA disease, according to the revision by Mountain CF of American Joint Committee on Cancer.
  • Treatment within the last 30 days with any investigational drug.
  • Cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
  • Active infection that in the opinion of the investigator would compromise the patient`s ability to tolerate therapy.
  • pregnancy/breast feeding
  • Serious concomitant disorders that would compromise the safety of the patient or compromise the patients ability to complete the study, at the discretion of the investigator.
  • poorly controlled diabetes mellitus
  • Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
  • History of significant neurological or mental disorder, including seizures or dementia.
  Contacts and Locations
Please refer to this study by its identifier: NCT00291850

AKH, Universitätsklinik für Innere Medizin 1
Vienna, Austria, 1090
Somogy Country Pulmo and Cardio Hospital,
Mosdos, Hungary
Markusovszky Hospital
Szombathely, Hungary
M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,
Warszawa, Poland, 02-781
Klinika Chirurgii Instytutu Gruzlicy i Chorob Pluc
Warszawa, Poland
Sponsors and Collaborators
Central European Cooperative Oncology Group
Principal Investigator: Maciej Krzakowski, MD M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw
  More Information

No publications provided

Responsible Party: Central European Cooperative Oncology Group Identifier: NCT00291850     History of Changes
Other Study ID Numbers: CECOG/NSCLC.3.2.002
Study First Received: February 14, 2006
Last Updated: April 30, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Central European Cooperative Oncology Group:

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic processed this record on April 17, 2014