NCT00294190

Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (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 weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.

Detailed description

All patients will receive weekly topotecan. Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)

Conditions

• Small Cell Lung Cancer
• Carcinoma, Small Cell

Interventions

Type	Name	Description
DRUG	Topotecan	Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-09-01
• Completion: 2009-07-01
• First posted: 2006-02-20
• Last updated: 2012-12-10

Locations

13 sites across 1 country: United States