We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

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.
ClinicalTrials.gov Identifier: NCT00616499
Recruitment Status : Unknown
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : February 15, 2008
Last Update Posted : February 9, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage IIIA non-small cell lung cancer.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: gefitinib Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • To assess the response rate to gefitinib treatment as preoperative induction therapy in patients with biopsy-proven stage IIIA (pN2) non-squamous non-small cell lung cancer accompanied by epidermal growth factor receptor (EGFR) mutations.

Secondary

  • To determine the complete resection rate in patients treated with this drug.
  • To determine the overall survival rate in patients treated with this drug.
  • To determine the disease-free survival rate in patients treated with this drug.
  • To determine the pathologic complete response rate in patients treated with this drug.
  • To determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once a day on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients with resectable disease may undergo surgery. Patients with unresectable disease may undergo surgery, chemotherapy, and/or radiotherapy.

After completion of study therapy, patients are followed for 2 years.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer
Study Start Date : November 2006
Estimated Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Complete resection rate
  2. Overall survival rate
  3. Median disease-free survival
  4. Complete pathological response rate
  5. Toxicity

Eligibility Criteria

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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Biopsy-proven stage IIIA nonsquamous non-small cell lung cancer

    • pN2 disease proven by mediastinoscopy
  • Meets any of the following criteria:

    • Never smoked
    • EGFR mutations (in exon 18, 19, or 21)*
    • FISH positive for EGFR* NOTE: *Irrespective of smoking history
  • Presence of at least 1 unidimensionally measurable lesion on thoracic CT scan, according to RECIST
  • Feasible to undergo pneumonectomy or lobectomy

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-1
  • FEV_1 ≥ 2.0 L in preoperative pulmonary function test
  • Hemoglobin ≥ 9.0 g/dL
  • WBC 4,000-12,000/μL
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3.0 times ULN
  • AST and ALT ≤ 3.0 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Negative pregnancy test

Exclusion criteria:

  • Severe complications or infections
  • Pregnant or breast-feeding women
  • Clinically significant heart disease
  • Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
  • Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy, chemotherapy, hormone therapy, or target therapy
  • No other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00616499


Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Contact Person    82-2-2072-1742      
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Joo-Hang Kim, MD    82-2-2228-8131    kjhang@yuhs.ac   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Contact Person    82-2-3410-1247      
Asan Medical Center - University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Contact Person    82-2-3010-7282      
Sponsors and Collaborators
Yonsei University
Investigators
Study Chair: Joo-Hang Kim, MD Yonsei University
More Information

ClinicalTrials.gov Identifier: NCT00616499     History of Changes
Other Study ID Numbers: CDR0000582623
YONSEI-4-2006-0136
ZENECA-YONSEI-4-2006-0136
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: September 2008

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
large cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action