Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC)
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Gefitinib retreatment
Intervention description: phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous EGFR-TKI failure.
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gefitinib; Recurrence; Carcinoma, Non-Small-Cell Lung

Summary:

      A single arm, open label, prospective, phase II trial of Gefitinib retreatment for the
      advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And
      progressive disease should be observed with at least one prior regimen following previous
      gefitinib failure.

      Primary endpoint

        -  to assess Disease Control Rate (Remission + Stable disease)

      Secondary endpoints

        -  to assess the progression free survival
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) stage IV or IIIB patients
             after chemotherapy following gefitinib failure

          -  Male and female patients aged over 18 years

          -  World Health Organization (WHO) performance status 0-2 (those with performance status
             2 must have been stable with no deterioration over the previous 2 weeks)

          -  Had at least stable disease with previous Gefitinib treatment

          -  Had at least one anticancer agent therapy after gefitinib failure ;Following treatment
             with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
             (TKIs)- erlotinib or other TKIs should not be included in anticancer agent therapy.

          -  The current approved indication of Gefitinib is 2nd or 3rd line monotherapy for
             recurrent or metastatic NSCLC. However, in practice with off-label indication, it can
             also be used as a 1st line treatment at the patient's own expenses. Thus, in this
             trial gefitinib retreatment will be 3rd line or more.

          -  Measurable lesion according to Response Evaluation Criteria in Solid Tumors(RECIST)
             with at least one measurable lesion not previously irradiated, unless disease
             progression has been documented at that site.

          -  Provision of written informed consent

          -  Life expectancy of at least 12 weeks

        Exclusion Criteria:

          -  Evidence of clinically active Interstitial Lung Diseases (Patients with chronic,
             stable, radiographic changes who are asymptomatic need not be excluded)

          -  Expected life expectancy less than 2 months

          -  Known severe hypersensitivity to gefitinib or any of the excipients of this product

          -  Any unresolved chronic toxicity greater that Common Terminology Criteria (CTC) grade 2
             from previous anticancer therapy

          -  As judged by the investigator, any evidence of severe or uncontrolled systemic disease
             (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

          -  Serum bilirubin greater than 3 times the upper limit of reference range (ULRR)

          -  Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x
             Upper Limit Normal (ULN) if no demonstrable liver metastases (or >5 x in presence of
             liver metastases)

          -  Evidence of any other significant clinical disorder or laboratory finding that makes
             it undesirable for the subject to participate in the study

          -  Pregnancy or breast-feeding women (women of child¬bearing potential). Women of
             childbearing potential must practice acceptable methods of birth control to prevent
             pregnancy.

          -  Newly diagnosed central nervous system (CNS) metastases that have not yet been treated
             with surgery and/or radiation. Patients with previously diagnosed and treated CNS
             metastases or spinal cord compression may be considered if they have evidence of
             clinically stable disease (no steroid therapy or steroid dose being tapered) for at
             least 2 weeks