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

Extensive-stage Small Cell Lung Cancer Clinical Trial

Official title:

Cisplatin Combined With Irinotecan or Etoposide for Untreated Extensive-stage Small Cell Lung Cancer: a Multicenter Randomized Control Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323737
• Other study ID #: CH-L-022
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2014
• Last updated: December 29, 2014
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: December 2014
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extensive-stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Irinotecan and cisplatin

• Etoposide and cisplatin

Locations

Country	Name	City	State
China	Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	China-Japan Friendship Hospital, Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		1 month	No