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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: therapeutic conventional surgery; Procedure: neoadjuvant therapy; Drug: gefitinib

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Contact Person; Phone Number: 82-2-2072-1742
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Contact Person; Phone Number: 82-2-3410-1247
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Yonsei Cancer Center at Yonsei University Medical Center
    • Contact: Joo-Hang Kim, MD; Phone Number: 82-2-2228-8131; Email: kjhang@yuhs.ac
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Asan Medical Center - University of Ulsan College of Medicine
    • Contact: Contact Person; Phone Number: 82-2-3010-7282

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Secondary Outcome Measures

Outcome Measure
Toxicity
Overall survival rate
Complete resection rate
Median disease-free survival
Complete pathological response rate

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Anticipated): November 1, 2010

Study Registration Dates

• First Submitted: February 14, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): February 9, 2009
• Last Update Submitted That Met QC Criteria: February 6, 2009
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: stage IIIA non-small cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Gefitinib
• Other Study ID Numbers: CDR0000582623; YONSEI-4-2006-0136; ZENECA-YONSEI-4-2006-0136