Finding studies
Finding studies
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Lead
Jonsson Comprehensive Cancer Center
With
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of escalating doses of exemestane when given with pemetrexed (pemetrexed disodium) and carboplatin in post-menopausal women with stage IV non-squamous, non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. Determine the objective tumor response rate (defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) in patients treated with pemetrexed, carboplatin and exemestane. II. Evaluate the pharmacokinetic profile of pemetrexed, carboplatin and exemestane. III. Evaluate quality of life in patients treated with pemetrexed, carboplatin and exemestane. IV. Analyze tumor tissue biomarkers for potential correlation with response. OUTLINE: This is a dose-escalation study of exemestane. Patients receive exemestane orally (PO) once daily (QD) on days 1-28 and pemetrexed disodium intravenously (IV) over 15 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and then every 3 months thereafter.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
