NCT01664754

Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer

Phase I Dose Escalation Study of Carboplatin, Pemetrexed and Exemestane in Post-menopausal Women With Metastatic Non-squamous NSCLC

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	exemestane	Given PO
DRUG	pemetrexed disodium	Given IV
DRUG	carboplatin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2012-09-07
• Primary completion: 2019-01-11
• Completion: 2019-01-11
• First posted: 2012-08-14
• Last updated: 2019-05-07

Locations

1 site across 1 country: United States