Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wen-zhao ZHONG, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT00600587
First received: January 14, 2008
Last updated: June 23, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the value of induction Erlotinib therapy before thoracotomy or radiotherapy in ⅢA-N2 (confirmed by mediastinoscopy or PET) 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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study of Induction Erlotinib Therapy in Stage III A(N2) Non-small Cell Lung Cancer Proceeding to Mediastinoscopy/PET and Thoracotomy/Radiotherapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response to Neoadjuvant Erlotinib Therapy [ Time Frame: a week after completion of the induction erlotinib therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease free survival [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: every 3 months ] [ 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 ]

Enrollment: 24
Study Start Date: September 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status: activating mutation)
Drug: neoadjuvant erlotinib therapy
150mg erlotinib taken once daily and continued uninterrupted for 42 days before evaluation/thoracotomy/radiotherapy.
Other Name: tarceva
Active Comparator: B
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/radiotherapy.
Other Name: gemzar

Detailed Description:

Stage IIIA non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) may result in dramatic responses in patients with pulmonary adenocarcinoma carrying EGFR activating mutations. In case reports, the efficacy of perioperative EGFR-TKI therapy in patients with locally advanced NSCLC harboring EGFR gene mutations was satisfactory. Although no prospective data support the use of EGFR-TKIs as induction therapy in stage IIIA-N2 NSCLC, their low toxicity profile and the possibility of a rapid tumor response suggests that prospective trials are required. Therefore, this study evaluated the value of induction erlotinib therapy in IIIA-N2 NSCLC selected by EGFR gene analysis and explored a new treatment strategy for this subset. Erlotinib specifically targets the EGFR TK domain, which is highly expressed and occasionally mutated in various forms of cancer. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor.

  Eligibility

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

Inclusion Criteria:

  • Written informed consent
  • Histological or cytological documented
  • Resectable NSCLC of stage IIIA-N2 confirmed by mediastinoscopy or PET
  • Naive therapy NSCLC
  • Candidates should be tolerated with induction therapy and thoracotomy with ECOG performance status 0-2, adequate haematological and Hepatic- renal function and qualified lung function
  • Enough tissue samples to perform gene analysis

Exclusion Criteria:

  • Small cell lung cancer
  • Pregnant or breast-feeding women
  • Any unstable systemic disease
  • Patients with exposure to investigational drug therapy or other concurrent anticancer therapy outside of this trial
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Locations
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
Principal Investigator: Yi-long WU, MD Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences
Study Chair: Xue-ning YANG, MD Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences
Study Director: Wen-zhao ZHONG, MD Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences
  More Information

Publications:

Responsible Party: Wen-zhao ZHONG, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT00600587     History of Changes
Other Study ID Numbers: CSLC-0702, tarceva-123456-1
Study First Received: January 14, 2008
Last Updated: June 23, 2013
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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Erlotinib
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014