Study to Assess Safety/Tolerability/Efficacy of Gefitinib Versus Docetaxel in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Gefitinib; CT or MRI; Docetaxel
Intervention description: 250 mg oral; performed at screening and every 6 weeks; 60mg/m2 intravenous infusion
Intervention MeSH terms: Docetaxel; Gefitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Locally Advanced or Metastatic NSCL Cancer

Summary:

      This is a randomized, open- label, parallel group, phase IV, multicentre study. The total
      number of patients expected to be recruited is 40. These randomized patients will have a
      histologically or cytologically confirmed adenocarcinoma histology of locally advanced or
      metastatic NSCLC. Patients will be recruited by investigational sites that have expertise in
      treating patients with non-small cell lung cancer. The study will compare gefitinib
      monotherapy 250 mg/day orally with docetaxel 60 mg/m2 intravenously over 1 hour every 3 weeks
      with a primary endpoint of safety and tolerability. The target population will be patients
      who have received one prior platinum-based chemotherapy and are now considered suitable
      candidates for further chemotherapy with docetaxel. At study entry, patients will be
      randomized on a 1:1 basis stratified with respect to performance status (0-1 vs. 2). Patients
      may continue to receive treatment with either gefitinib or docetaxel until disease
      progression, unacceptable toxicity or the occurrence of any of the other specific criteria.
      An independent committee will be appointed to perform a blinded review of all patient scans.
      Any assessments/visits after screening should be performed within a window of plus or minus 3
      working days of the scheduled visit date. If selected screening evaluations are done within 7
      days of Day 1, Cycle 1 of treatment, and are acceptable for study entry, they do not have to
      be repeated on Day 1 unless the investigator believes that they are likely to have
      significantly changed. Any patient who discontinues from study treatment without radiological
      evidence of disease progression (except for withdrawal of consent by patient) should continue
      to have objective tumor assessments every 6 weeks in order to collect information on
      progression of disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC, not amenable to curative
             surgery or radiotherapy

          -  Treatment with one prior chemotherapy regimen, which must have been platinum based*
             *Patients must have demonstrated radiological or clinical progression since completion
             of previous chemotherapy regimen.

          -  Adequate hepatic function, defined as BOTH a bilirubin < upper limit of reference
             range (ULRR) AND an "Eligible" combination of transaminases (aspartate
             aminotransferase (AST) or alanine aminotransferase (ALT)) and alkaline phosphatase
             (ALP) below: Not Eligible: AST or ALT > 5xULRR, 1.5xULRR < AST or ALT < 5xULRR and
             ALP> ULRR, 1xULRR < AST or ALT < 1.5xULRR and ALP> 2.5xULRR, AST or ALT <= ULRR and
             ALP> 5xULRR For more information please refer to TAXOTERE® (docetaxel) prescribing
             information

        Exclusion Criteria:

          -  Prior therapy with gefitinib or other EGFR TK inhibitors (HER-1 receptor
             inhibitors/small molecule or monoclonal antibody therapy)

               -  Prior docetaxel treatment for NSCLC

               -  Patients with pre-existing peripheral neuropathy ³ grade 2 (NCI CTCAE criteria)

               -  Past medical history of interstitial lung disease, drug induced interstitial
                  disease, radiation pneumonitis that required steroid treatment or any evidence of
                  clinically active interstitial lung disease