NCT00400829

E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase 2 Study of the Halichondrin B Analog E7389 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a Taxane

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well E7389 works in treating patients with recurrent or progressive stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description

OBJECTIVES: I. Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer. II. Evaluate the time to progression and overall survival of patients treated with this drug. III. Evaluate the toxicity profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed once monthly for at least 6 months and then periodically thereafter.

Conditions

• Recurrent Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	eribulin mesylate	Given IV

Timeline

• Start date: 2006-11-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2006-11-17
• Last updated: 2015-01-07
• Results posted: 2015-01-07

Locations

2 sites across 1 country: United States