Neoadjuvant Erlotinib Therapy in Stage III A(N2) NSCLC - Full Text View

Purpose

The purpose of this study is to evaluate the value of neoadjuvant Erlotinib therapy before thoracotomy in ⅢA-N2(confirmed by mediastinoscopy) non-small cell lung cancer(NSCLC) selected by epidermal growth factor receptor(EGFR) gene analysis and initial to explore a new treatment strategy for ⅢA-N2 NSCLC.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: neoadjuvant erlotinib therapy Drug: neoadjuvant gemcitabine/carboplatin therapy	Phase II

MedlinePlus related topics:

Cancer Lung Cancer

Drug Information available for:

Carboplatin Gemcitabine hydrochloride Gemcitabine Erlotinib Erlotinib hydrochloride Tyrosine

U.S. FDA Resources

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

Official Title:	Phase Ⅱ Study of Neoadjuvant Erlotinib Therapy in Stage III A(N2) Non-Small Cell Lung Cancer Proceeding to Mediastinoscopy and Surgery

Further study details as provided by Guangdong Provincial People's Hospital:

Primary Outcome Measures:

Response to Neoadjuvant Erlotinib Therapy [ Time Frame: 14 days after Neoadjuvant Erlotinib Therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

disease free survival [ Time Frame: by follow up ] [ Designated as safety issue: No ]
overall survival [ Time Frame: by follow up ] [ Designated as safety issue: No ]
complete resection rate [ Time Frame: 7 days after thoractomy ] [ Designated as safety issue: No ]
Toxicity of Neoadjuvant Erlotinib Therapy and postoperative complications [ Time Frame: one months after thoractomy ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	46
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status:mutant-type OR high copy number OR (overexpression AND non-smokers))	Drug: neoadjuvant erlotinib therapy 150mg erlotinib taken once daily and continued uninterrupted for 30 days before evaluation/thoracotomy.
B: Active Comparator Non-erlotinib targeted NSCLC population based on EGFR gene analysis	Drug: neoadjuvant gemcitabine/carboplatin therapy 3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Resectable NSCLC of stage ⅢAN2 confirmed by mediastinoscopy.
Naive therapy NSCLC.
Candidates should be tolerated with neoadjuvant therapy and thoracotomy with ECOG performance status 0-2 and qualified lung function.

Exclusion Criteria:

SCLC.
Unresectable NSCLC of stage ⅢAN2.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600587

Contacts


Contact: Yi-long WU, MD	+86-020-83821484	gzyilong2006@hotmail.com

Contact: Xue-ning YANG, MD	+86-020-83821484	yangxuening@gmail.com

Locations


China, Guangdong
	Guangdong Provincial People's Hospital	Recruiting
	Guangzhou, Guangdong, China, 510080
	Contact: Yi-long WU, MD +86-13609777314 gzyilong2006@hotmail.com
	Contact: Xue-ning YANG, MD +86-020-83827712 yangxuening@gmail.com
	Principal Investigator: Yi-long WU, MD

Sponsors and Collaborators

Guangdong Provincial People's Hospital

Hoffmann-La Roche

Investigators


Principal Investigator:	Yi-long WU, MD	Guangdong Provincial People's Hospital

Study Chair:	Xue-ning YANG, MD	Guangdong Provincial People's Hospital

Study Director:	Wen-zhao ZHONG, MD	Guangdong Provincial People's Hospital

More Information

Publications:

Wu YL, Zhong WZ, Li LY, Zhang XT, Zhang L, Zhou CC, Liu W, Jiang B, Mu XL, Lin JY, Zhou Q, Xu CR, Wang Z, Zhang GC, Mok T. Epidermal growth factor receptor mutations and their correlation with gefitinib therapy in patients with non-small cell lung cancer: a meta-analysis based on updated individual patient data from six medical centers in mainland China. J Thorac Oncol. 2007 May;2(5):430-9.

Costa DB, Kobayashi S, Tenen DG, Huberman MS. Pooled analysis of the prospective trials of gefitinib monotherapy for EGFR-mutant non-small cell lung cancers. Lung Cancer. 2007 Oct;58(1):95-103. Epub 2007 Jul 3.

Responsible Party:	Lung Cancer Research Institute, Guangdong Provincial People's Hospital ( Yi-long WU )
Study ID Numbers:	CSLC-0702, ROCHE-123456-1
First Received:	January 14, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00600587
Health Authority:	China: Ethics Committee

Keywords provided by Guangdong Provincial People's Hospital:

Carcinoma, Non-Small-Cell Lung

Genes, erbB-1

tyrosine kinase inhibitor

Neoadjuvant Therapy

Study placed in the following topic categories:

Erlotinib

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carboplatin

Gemcitabine

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Antimetabolites

Respiratory Tract Neoplasms

Anti-Infective Agents

Neoplasms by Histologic Type

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Protein Kinase Inhibitors

Immunosuppressive Agents

Antiviral Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2008

Sponsors and Collaborators:	Guangdong Provincial People's Hospital Hoffmann-La Roche
Information provided by:	Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier:	NCT00600587