NCT00315211

Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Aultman Health Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are: * To determine the overall response rate of patients treated with at least 2 cycles of this regimen. * To determine the feasibility and toxicity of the combination of topotecan and docetaxel.

Detailed description

The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles. Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.

Conditions

• Mediastinal Neoplasms

Interventions

Type	Name	Description
DRUG	Intravenous Topotecan	Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
DRUG	Intravenous Docetaxel	Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 \& 8 of a 21 day cycle

Timeline

• Start date: 2004-11-01
• Primary completion: 2007-06-01
• Completion: 2007-11-08
• First posted: 2006-04-18
• Last updated: 2018-08-20

Locations

1 site across 1 country: United States