Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).|
- Median time to progression of disease [ Time Frame: at off-treatment, up to 18 weeks ] [ Designated as safety issue: No ]
- Safety Profile Based on Number of Patients With Each Worst-grade Toxicity [ Time Frame: 30 days after completing treatment ] [ Designated as safety issue: Yes ]
- Response rate [ Time Frame: at off-treatment, up to 18 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: date on study to progression-free survival ] [ Designated as safety issue: No ]
- Overall survival rate [ Time Frame: date on study to date of death from any cause ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Drug: bendamustine hydrochloride
Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle
- 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.
|United States, Kentucky|
|Hardin Memorial Hosptial|
|Elizabethtown, Kentucky, United States, 42701|
|United States, Tennessee|
|The Jones Clinic - Germantown|
|Germantown, Tennessee, United States, 38138|
|Jackson-Madison County Hospital|
|Jackson, Tennessee, United States, 38301|
|Baptist Regional Cancer Center at Baptist Riverside|
|Knoxville, Tennessee, United States, 37901|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Vanderbilt-Ingram Cancer Center - Cool Springs|
|Nashville, Tennessee, United States, 37064|
|Principal Investigator:||Leora Horn, M.D.||Vanderbilt-Ingram Cancer Center|