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

Titre officiel

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

Sommaire:

Cette étude a pour but de déterminer l’innocuité et l’efficacité du traitement par le pemetrexed et le cisplatine administré en concomitance avec une radiothérapie à fortes doses chez les patients atteints d’un cancer du poumon non à petites cellules de stade IIIA ou B, non résécable, mais potentiellement guérissable.

Description de l'essai

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.

Voir cet essai sur ClinicalTrials.gov