Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00984542|
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : March 12, 2014
Last Update Posted : March 12, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: bendamustine hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Drug: bendamustine hydrochloride
Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle
- Time to Progression [ Time Frame: On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days) ]Estimated probable duration from on-study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.
- Number of Patients With Each Worst-grade Toxicity [ Time Frame: Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days ]Number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.
- Best Response [ Time Frame: On‐treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days) ]
Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details):
complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.
- Progression-free Survival [ Time Frame: On‐study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days) ]Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.
- Overall Survival [ Time Frame: On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months ]Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984542
|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 - Cool Springs|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Leora Horn, M.D.||Vanderbilt-Ingram Cancer Center|