NCT00984542

Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line therapy in treating patients with relapsed or refractory small cell lung cancer.

Detailed description

OBJECTIVES: Primary * To determine the time to progression in patients with relapsed or refractory small cell lung cancer treated with second- or third-line bendamustine. Secondary * To determine the toxicity of this drug in these patients. * To determine the response rate, progression-free survival, and overall survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6-8 weeks.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	bendamustine hydrochloride	Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2009-09-25
• Last updated: 2014-03-12
• Results posted: 2014-03-12

Locations

6 sites across 1 country: United States