Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase I Dose Escalation Study of Carboplatin, Pemetrexed and Exemestane in Post-menopausal Women With Metastatic Non-squamous NSCLC
This phase I trial studies the side effects and best dose of exemestane in combination with pemetrexed disodium and carboplatin in treating post-menopausal women with stage IV non-small cell lung cancer. Exemestane may stop the growth of tumor calls by blocking some of the enzymes need for cell growth. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving exemestane together with pemetrexed disodium and carboplatin may kill more tumor cells
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.
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