NCT00143455

Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer

Open Label, Randomised Multicentre Phase III Study Of Irinotecan Hydrochloride (Campto (Registered)) And Cisplatin Versus Etoposide And Cisplatin In Chemotherapy Naive Patients With Extensive Disease - Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Etoposide + cisplatin	etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle
DRUG	Irinotecan + cisplatin	irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle

Timeline

• Start date: 2002-06-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2005-09-02
• Last updated: 2010-02-18
• Results posted: 2010-01-21

Locations

67 sites across 13 countries: Austria, Belgium, Czechia, Egypt, France, Germany, Italy, Netherlands, Poland, Russia, Spain, Switzerland, Taiwan