Phase II Trial of Dose-Dense Paclitaxel and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Stage II and IIA NSCLC - Full Text View

Sponsored by:	Central European Cooperative Oncology Group
Information provided by:	Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00291850

Purpose

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 II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Paclitaxel Pegfilgrastim Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

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.

Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00291850

Locations

Austria
AKH, Universitätsklinik für Innere Medizin 1
Vienna, Austria, 1090
Hungary
Markusovszky Hospital
Szombathely, Hungary
Somogy Country Pulmo and Cardio Hospital,
Mosdos, Hungary
Poland
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

Investigators

Principal Investigator:

Maciej Krzakowski, MD

M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw

More Information

Study ID Numbers:	CECOG/NSCLC.3.2.002
Study First Received:	February 14, 2006
Last Updated:	May 10, 2007
ClinicalTrials.gov Identifier:	NCT00291850
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Central European Cooperative Oncology Group:

NSCLC

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Carcinoma
Naphazoline
Oxymetazoline
Cisplatin
Respiratory Tract Diseases
Guaifenesin

Lung Neoplasms
Paclitaxel
Phenylephrine
Lung Diseases
Phenylpropanolamine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009