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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 2

Conditions: Extensive-stage Small Cell Lung Cancer

Treatments: Drug: Irinotecan and cisplatin; Drug: Etoposide and cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02323737

CH-L-022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Irinotecan and cisplatin

Active Comparator group

Description:

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.

Treatment:

Drug: Irinotecan and cisplatin

Etoposide and Cisplatin

Active Comparator group

Description:

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.

Treatment:

Drug: Etoposide and cisplatin