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

NCT00616499 | Unknown Phase 2

• 3 other identifiers: CDR0000582623YONSEI-4-2006-0136ZENECA-YONSEI-4-2006-0136
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

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.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

Secondary Outcomes (5)

• Complete resection rate

• Overall survival rate

• Median disease-free survival

• Complete pathological response rate

• Toxicity

Interventions

gefitinib DRUG

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (4)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Asan Medical Center - University of Ulsan College of Medicine

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Gefitinib; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics

Study Officials

• Joo-Hang Kim, MD

  Yonsei University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 15, 2008
• Study Start: November 1, 2006
• Primary Completion: November 1, 2010
• Last Updated: February 9, 2009

Record last verified: 2008-09

Locations

KR (4)