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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00616499
First received: February 14, 2008
Last updated: February 6, 2009
Last verified: September 2008
  Purpose

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 Intervention Phase
Lung Cancer
Drug: gefitinib
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete resection rate [ Designated as safety issue: No ]
  • Overall survival rate [ Designated as safety issue: No ]
  • Median disease-free survival [ Designated as safety issue: No ]
  • Complete pathological response rate [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: November 2006
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00616499

Locations
Korea, Republic of
Asan Medical Center - University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Contact Person    82-2-3010-7282      
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Contact Person    82-2-3410-1247      
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   
Sponsors and Collaborators
Yonsei University
Investigators
Study Chair: Joo-Hang Kim, MD Yonsei University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00616499     History of Changes
Other Study ID Numbers: CDR0000582623, YONSEI-4-2006-0136, ZENECA-YONSEI-4-2006-0136
Study First Received: February 14, 2008
Last Updated: February 6, 2009
Health Authority: Unspecified

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014