Effects of Carboplatin and Gemcitabine on Stage IIIB Pleural Effusion and Stage IV Lung Cancer
Stage IV Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Stage IV Non-small Cell Lung Cancer focused on measuring Untreated, Lung, Cancer, non-small cell, gemcitabine, gemzar, carboplatin, dexamethasone
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.
Sites / Locations
- Commonwealth Cancer Center
- Markey Cancer Center
- Brown Cancer Center
- St. Claire Regional Medical Center
- Montgomery Cancer Center
- Owensboro Medical HealthCare System
- West Kentucky Hematology & Oncology Group, PSC
Arms of the Study
Arm 1
Arm 2
Other
Experimental
1 No Dex
2 Dex
No Dexamethasone
Dexamethasone