A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer

Official Title

A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer

Summary:

The purpose of this study is to determine the safety and efficacy of the combination of pemetrexed and cisplatin given concurrently with high dose radiation treatment in patients with unresectable but potentially curable stage IIIA/B non-small cell lung cancer.

Trial Description

Primary Outcome:

• Toxicity (Phase I)
• Overall Survival (phase II)

Secondary Outcome:

• Dose Limiting Toxicity (Phase I)
• Response Rate (RECIST)
• Time to disease progression
• Progression free survival
• Site of first failure
• Local control
• Overall survival

Concurrent chemoradiation is the accepted standard of care for most patients with unresectable stage III A/B non-small cell lung cancer (NSCLC) but no standard chemotherapy regimen or schedule has yet been established. Cisplatin, combined with a third generation agent, provides the greatest activity in advanced NSCLC but, to date, no third generation agent has been shown to be tolerable at full dose in combination with radiotherapy (RT) and cisplatin. Pemetrexed/cisplatin (PemC) has shown promising activity in the advanced disease setting and full dose pemetrexed combined with RT or RT/carboplatin appears tolerable. This study was therefore designed to find the maximum tolerable dose of concurrent pemetrexed and cisplatin delivered concurrently with radiation, determine the recommended phase II dose of this regimen and then assess its efficacy in a phase II trial.

View this trial on ClinicalTrials.gov