CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 485 enrolled
Drug / intervention
Etoposide + cisplatin +1 moredrug
Likely dose
Irinotecan 65 mg/m² on days 1 and 8 + cisplatin 80 mg/m² on day 1, 3-week cycle (experimental arm); or etoposide 100 mg/m² on days 1–3 + cisplatin 80 mg/m² on day 1, 3-week cycle (comparator arm)AI-extracted
Key inclusion· 3
  • ✓Histologically or cytologically proven Small Cell Lung Cancer (SCLC)
  • ✓WHO performance status 0 or 1
  • ✓Chemotherapy-naive (extensive disease)
Key exclusion· 2
  • ✕Prior radiotherapy is not allowed except on bone metastases when newly diagnosed
  • ✕Prior surgery on the primary tumor not allowed except for palliative purpose (e.g., stent for vena cava syndrome)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00143455
NCT00143455Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted Sep 2, 2005·Updated Feb 18, 2010

In Brief

A Phase 3 clinical trial evaluating Etoposide + cisplatin and Irinotecan + cisplatin for Small Cell Lung Carcinoma. Completed, enrolled 485 participants across 67 sites in 13 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Carcinoma
CountriesAustria, Belgium, Czechia, Egypt, France, Germany, Italy, Netherlands, Poland, Russia, Spain, Switzerland, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2, 2005
Enrollment StartJun 1, 2002
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 20.8 years ago

Interventions

Etoposide + cisplatindrug

etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle

Irinotecan + cisplatindrug

irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle