NCT00447421

A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy

Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.

Conditions

• Small Cell Lung Cancer
• Carcinoma, Small Cell
• SCLC

Interventions

Type	Name	Description
DRUG	pemetrexed	Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation) Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
DRUG	cisplatin	Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
RADIATION	radiation	Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-03-14
• Last updated: 2009-10-28
• Results posted: 2009-08-26

Locations

4 sites across 2 countries: Belgium, Netherlands