Phase II Study of Irinotecan and Cisplatin in Extensive-stage Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Extensive-stage Small Cell Lung Cancer
• Interventions: Drug: Etoposide and cisplatin; Drug: Irinotecan and cisplatin

• Registration Number: NCT02323737
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of efficacy and toxicity of IP regimen was analyzed.

Detailed Description

This is a randomized, multicenter study. Patients are randomized to irinotecan/cisplatin (IP) or etoposide/cisplatin (EP) treatment arms. The IP regimen consisted of at most 6 cycles of irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface area on day 1. The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1. Cycle length for the two arms was 3 weeks. The dose adjustment was allowed in at most within ±5% per investigator discretion if necessary.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Status Verified: 2014-12
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) of 0 to 2
• A life expectancy of at least 3 months
• Measurable lesions
• Adequate hematologic function

Exclusion Criteria

• Infection
• Myocardial infarction within the preceding three months
• Symptomatic brain metastases or receiving radiotherapy less than 4 weeks
• Pregnancy or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etoposide and Cisplatin	Etoposide and cisplatin	The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1.
Irinotecan and cisplatin	Irinotecan and cisplatin	The IP regimen consisted of at most 6 cycles of irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface area on day 1.

Primary Outcome Measures

Name	Time	Method
progression-free survival	1 month

Trial Locations

Locations (1)

Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; 🇨🇳 Beijing, Beijing, China