Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).
- To determine the time to progression in patients with relapsed or refractory small cell
lung cancer treated with second- or third-line bendamustine.
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median time to progression of disease
at off-treatment, up to 18 weeks
Leora Horn, M.D.
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC THO 0920
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Jackson-Madison County Hospital||Jackson, Tennessee 38301|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Baptist Regional Cancer Center at Baptist Riverside||Knoxville, Tennessee 37901|
|The Jones Clinic - Germantown||Germantown, Tennessee 38138|
|Hardin Memorial Hosptial||Elizabethtown, Kentucky 42701|