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Status:

UNKNOWN

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

Lead Sponsor:

Yonsei University

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 norm...

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 acc...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    35 Patients enrolled

    Trial Details

    Trial ID

    NCT00616499

    Start Date

    November 1 2006

    Last Update

    February 9 2009

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Seoul National University Hospital

    Seoul, South Korea, 110-744

    2

    Yonsei Cancer Center at Yonsei University Medical Center

    Seoul, South Korea, 120-752

    3

    Samsung Medical Center

    Seoul, South Korea, 135-710

    4

    Asan Medical Center - University of Ulsan College of Medicine

    Seoul, South Korea, 138-736