NCT00305942

Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage SCLC.

Detailed description

Eligible patients will receive treatment with carboplatin and topotecan. Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . \- Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)

Conditions

• Carcinoma, Small Cell

Interventions

Type	Name	Description
DRUG	Topotecan	Topotecan 4mg/m2 IV on days 1, 8.
DRUG	carboplatin	Carboplatin AUC=5 IV day 1 only .

Timeline

• Start date: 2006-03-01
• Primary completion: 2009-04-01
• Completion: 2009-11-01
• First posted: 2006-03-22
• Last updated: 2013-01-31
• Results posted: 2013-01-24

Locations

16 sites across 1 country: United States