NCT00320359

Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer

An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer

Conditions

• Lung Cancer, Small Cell

Interventions

Type	Name	Description
DRUG	Intravenous topotecan/cisplatin	Topotecan 1 mg/m2 should be administered intravenously over a period of 30 minutes on days 1-5. Then a 30 minute saline flush should be administered followed by the cisplatin on day 5. Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 5 after topotecan.
DRUG	Intravenous etoposide/cisplatin	Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 1. Cisplatin should be given simultaneously to post-hydration to ensure a high volume fluid. Etoposide 100 mg/m2 should be administered after cisplatin intravenously over a period not less than 30 minutes on days 1 -3.

Timeline

• Start date: 2002-08-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2006-05-03
• Last updated: 2017-03-01

Locations

79 sites across 2 countries: Austria, Germany