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.
Subjects enrolled in the study will be placed in one of two treatment arms. All subjects have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given pre-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Commonwealth Cancer Center
Danville, Kentucky, United States
Markey Cancer Center
Lexington, Kentucky, United States
Brown Cancer Center
Louisville, Kentucky, United States
St. Claire Regional Medical Center
Morehead, Kentucky, United States
Percentage of Participants With Reduction in Grade 3/4 Neutropenia
Reduction grade 3/4 neutropenia
Time frame: continuous throughout treatment, up to 25 weeks
Effect of Dexamethasone Pre-treatment on Response Rate.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment
Effect of Dexamethasone Pre-treatment on Overall Survival.
Overall survival
Time frame: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days
Progression-free Survival
progression-free survival
Time frame: Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days
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Montgomery Cancer Center
Mount Sterling, Kentucky, United States
Owensboro Medical HealthCare System
Owensboro, Kentucky, United States
West Kentucky Hematology & Oncology Group, PSC
Paducah, Kentucky, United States