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

Phase 2 Completed 38 enrolled SCRI Development Innovations, LLC GlaxoSmithKline · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2006-02
Primary completion: 2007-09
Completion: 2009-07

Outcome

Missed primary endpoint

paper does not improve efficacy in patients with relapsed SCLC. PMID 21663862 ↗

Publications

Spigel DR, Greco FA, Burris HA 3rd, Shipley DL, Clark BL, Whorf RC, Arrowsmith ER, Hainsworth JD. A phase II study of higher dose weekly topotecan in relapsed small-cell lung cancer. Clin Lung Cancer. 2011 May;12(3):187-91. doi: 10.1016/j.cllc.2011.03.016. Epub 2011 Apr 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topotecan	Small molecule	6 mg/m2	Intravenous