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

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Paclitaxel, Cisplatin, Pegfilgrastim Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. >To evaluate the safety of neo-adjuvant chemotherapy with PC
  2. - to characterize the toxicity of PC, include febrile neutropenia.
  3. - to evaluate peri- and post-operative mortality
  4. > to determine the pathological complete response rate
  5. > to determine the complete tumor resection rate
  6. > 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.
  7. > To evaluate the following time-to-event efficacy variables:
  8. - disease free survival
  9. - overall survival
  10. > to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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 identifier (NCT number): 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

Responsible Party: Central European Cooperative Oncology Group Identifier: NCT00291850     History of Changes
Other Study ID Numbers: CECOG/NSCLC.3.2.002
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Central European Cooperative Oncology Group:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action