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. Identifier: NCT00291850
Recruitment Status : Terminated (no patient recruitment)
First Posted : February 15, 2006
Last Update Posted : May 1, 2012
Information provided by (Responsible Party):
Central European Cooperative Oncology Group

February 14, 2006
February 15, 2006
May 1, 2012
June 2005
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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
Same as current
Complete list of historical versions of study NCT00291850 on Archive Site
  • >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)
Same as current
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Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer
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.

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.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: Paclitaxel, Cisplatin, Pegfilgrastim
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Hungary,   Poland
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Central European Cooperative Oncology Group
Central European Cooperative Oncology Group
Not Provided
Principal Investigator: Maciej Krzakowski, MD M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw
Central European Cooperative Oncology Group
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP