Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer
Condition: Stage IV Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion
Intervention: Gemcitabine; Dexamethasone; Carboplatin
Intervention description: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.; 16 mg bid for 4 days prior to each chemotherapy start.; AUC 6.0 intravenously over 30 minutes on day 5.
Intervention MeSH terms: Dexamethasone; Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Untreated; Lung; Cancer; non-small cell; gemcitabine; gemzar; carboplatin; dexamethasone

Summary:

      The purpose of this study is to find better treatment for lung cancer and to find out what
      effects the combined treatment of carboplatin and gemcitabine when given with or without
      dexamethasone have on cancer.

      This study will determine if dexamethasone, when given before standard chemotherapy will
      increase the cancer fighting effects and reduce the side effects of chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Untreated, stage IIIB with pleural effusion

          -  Untreated, Stage IV, non-small cell lung cancer

          -  Recurrent after surgery if no previous radiation therapy or chemotherapy were
             administered as part of their primary treatment, except for palliative radiotherapy

          -  18 years of age or older

          -  ECOG PS 0, 1 or 2

          -  At Least one target lesion according to the RECIST Criteria

          -  Adequate organ and marrow function

        Exclusion Criteria:

          -  Previous cancer history unless they have had curative treatment completed at least 5
             years prior to entry.

          -  No previous radiotherapy, chemotherapy or immunotherapy for NSCLC, except for
             radiation therapy to the brain to control metastasis, bone to control pain, or lung to
             relieve bronchial obstruction.

          -  No radiation therapy for any previous cancer to more than 25% of bone marrow.

          -  Uncontrolled, intercurrent illness

          -  Non-study corticosteroids

          -  Pregnant women

          -  Peripheral neuropathy greater than grade 1

          -  Uncontrolled seizures, central nervous system disorders

          -  Major surgery within 4 weeks of the start of study treatment

          -  Lack of complete recovery from major surgery.

          -  Glaucoma

          -  Lack of physical integrity of upper gastrointestinal tract, inability to swallow
             tablets

          -  Severe acquired or hereditary immunodeficiency

          -  Patients with brain metastases must receive definitive treatment (radiation, surgery
             or both) and be clinically and radiologically stable for 4 weeks & off corticosteroids
             for at least 2 weeks prior to randomization.