NCT02171325

Study of Different Doses of Irinotecan and Cisplatin for First-line Extensive-stage Small-cell Lung Cancer Treatment

A Phase Ⅱ Study of Different Doses of Irinotecan and Cisplatin for First-line Extensive-stage Small-cell Lung Cancer Treatment

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify the appropriate dose of irinotecan by dose escalation(dose climbing) test. The study would provide rationale for regimen decision in a future phase III clinical trial, in which irinotecan combined with cisplatin(IP) will be selected as therapeutic drugs.

Detailed description

To determine the Maximum Tolerated Dose (MTD) and Limiting Toxicity (DLTs) of irinotecan in patients with extensive stage small cell lung cancer treated with irinotecan plus cisplatin

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	irinotecan	60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2

Timeline

• Start date: 2014-06-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2014-06-24
• Last updated: 2021-02-03

Locations

1 site across 1 country: China