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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gefitinib
neoadjuvant therapy
therapeutic conventional surgery
Sponsored by
Yonsei University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting
  • Yonsei Cancer Center at Yonsei University Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Asan Medical Center - University of Ulsan College of MedicineRecruiting

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2008
Last Updated
February 6, 2009
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT00616499
Brief Title
Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gefitinib
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
Response rate
Secondary Outcome Measure Information:
Title
Complete resection rate
Title
Overall survival rate
Title
Median disease-free survival
Title
Complete pathological response rate
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hang Kim, MD
Organizational Affiliation
Yonsei University
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
82-2-2072-1742
Facility Name
Yonsei Cancer Center at Yonsei University Medical Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Hang Kim, MD
Phone
82-2-2228-8131
Email
kjhang@yuhs.ac
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
82-2-3410-1247
Facility Name
Asan Medical Center - University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
82-2-3010-7282

12. IPD Sharing Statement

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

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