NCT00846443

Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer

A Phase I Study of Concurrent Pemetrexed, Cisplatin and Radiotherapy in Local Advanced Non-Small Cell Lung Cancer.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the recommended dose of pemetrexed and the maximum tolerated dose of radiotherapy when using concurrent pemetrexed/cisplatin/radiotherapy in the patients with local advanced non-small cell lung cancer.

Detailed description

This study was conducted to explore the feasibility of concurrent chemoradiation therapy with pemetrexed, cisplatin and radiotherapy in unresectable local advanced non-small cell lung cancer. We will perform the dose escalation of pemetrexed to determine if full dose (500mg/m2) of pemetrexed could be administrated concurrently with cisplatin and conventional dose radiotherapy (66Gy) firstly. Secondly, radiation dose will be escalated to determine the maximum tolerated dose (MTD) of radiotherapy when administered concurrently with full dose pemetrexed and cisplatin.

Conditions

• Local Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Concurrent Pemetrexed, Cisplatin and Radiotherapy	pemetrexed:400 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
OTHER	Concurrent Pemetrexed, Cisplatin and Radiotherapy	pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:66 Gy in 33 fractions
OTHER	Concurrent Pemetrexed, Cisplatin and Radiotherapy	pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:70 Gy in 35 fractions
OTHER	Concurrent Pemetrexed, Cisplatin and Radiotherapy	pemetrexed:500 mg/m2, IV, day 1 and day 22; cisplatin: 25 mg/m2, IV, days 1-3 and 22-24; radiotherapy:74 Gy in 37 fractions

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-01-01
• First posted: 2009-02-18
• Last updated: 2009-02-18

Locations

1 site across 1 country: China