This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is 1) to determine the relationship between dexamethasone dose, and hematoprotective activity in participants treated de novo with carboplatin and gemcitabine for metastatic non-small cell lung cancer; 2) to evaluate the effect of dexamethasone on the clinically relevant parameters of hematologic and non-hematologic toxicity; and 3) to undertake preliminary studies to examine mechanisms by which dexamethasone may reduce hematologic and non-hematologic toxicities of carboplatin and gemcitabine. Participants will be randomly assigned to Cohorts 1, 2, and 3 in a 1:2:2 ratio. At least 8 participants will be randomized to Cohort 1 (carboplatin/gemcitabine, control cohort) and a minimum of 16 participants will be accrued to each of the other two cohorts (Cohort 2: dexamethasone, 8 mg, plus carboplatin/gemcitabine; Cohort 3: dexamethasone, 16 mg, plus carboplatin/gemcitabine). Chemotherapy courses will occur every three weeks for up to four courses of treatment. A total of 40 evaluable participants will be needed for study evaluation. Participants not completing courses 1 and 2 due to voluntary withdrawal, toxicity, disease progression, or any other reason, will continue on study. Participants will continue on study until disease progression or will be treated on study for a maximum of four courses.
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