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

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ClinicalTrials.gov Identifier: NCT00984542
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : March 12, 2014
Last Update Posted : March 12, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Leora Horn, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Intervention Drug: bendamustine hydrochloride
Enrollment 50
Recruitment Details This study opened to accrual in September 2009 and closed to accrual in February 2012
Pre-assignment Details 59 patients consented, 9 were determined to be ineligible to participate
Arm/Group Title Bendamustine
Hide Arm/Group Description Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
Period Title: Overall Study
Started 50
Completed 9
Not Completed 41
Reason Not Completed
disease progression             19
toxicity             7
Death             7
complicating disease             3
Withdrawal by Subject             3
clinical deterioration             2
Arm/Group Title Bendamustine
Hide Arm/Group Description Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
Patients with Relapsed or Refractory Small Cell Lung Cancer (SCLC)who received study drug
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
  68.0%
>=65 years
16
  32.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
62  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
22
  44.0%
Male
28
  56.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Time to Progression
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients are included in the analysis on intention-to treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.
Arm/Group Title Bendamustine
Hide Arm/Group Description:
Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: days
123
(98 to 138)
2.Secondary Outcome
Title Number of Patients With Each Worst-grade Toxicity
Hide Description 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.
Time Frame Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of patients reported with any toxicity
Arm/Group Title Bendamustine
Hide Arm/Group Description:
Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
Number of patients with worst-grade toxicity of 1 1
Number of patients with worst-grade toxicity of 2 14
Number of patients with worst-grade toxicity of 3 21
Number of patients with worst-grade toxicity of 4 5
Number of patients with worst-grade toxicity of 5 9
3.Secondary Outcome
Title Best Response
Hide Description

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.

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)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response. 8 patients were not evaluable.
Arm/Group Title Bendamustine
Hide Arm/Group Description:
Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: participants
Complete Response 1
Partial Response 10
Progressive Disease 14
Stable Disease 17
4.Secondary Outcome
Title Progression-free Survival
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.
Arm/Group Title Bendamustine
Hide Arm/Group Description:
Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: days
98
(61 to 114)
5.Secondary Outcome
Title Overall Survival
Hide Description 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)
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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.
Arm/Group Title Bendatmustine
Hide Arm/Group Description:
Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: days
144
(110 to 182)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bendamustine
Hide Arm/Group Description Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
All-Cause Mortality
Bendamustine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bendamustine
Affected / at Risk (%) # Events
Total   27/50 (54.00%)    
Blood and lymphatic system disorders   
hemoglobin  3/50 (6.00%)  3
neutrophils/granulocytes  2/50 (4.00%)  2
thrombocytopenia  2/50 (4.00%)  2
Cardiac disorders   
atrial fibrillation  2/50 (4.00%)  2
troponin levels postive  1/50 (2.00%)  1
chest pain  1/50 (2.00%)  1
pericardial effusion-non-malignant  1/50 (2.00%)  1
Gastrointestinal disorders   
diarrhea  3/50 (6.00%)  3
nausea  4/50 (8.00%)  4
pain-abdomen NOS  1/50 (2.00%)  1
vomiting  2/50 (4.00%)  2
General disorders   
chills  1/50 (2.00%)  1
death not associated with CTCAE term-NOS  1/50 (2.00%)  1
death not associated with CTCAE term-disease progression  9/50 (18.00%)  9
fatigue  3/50 (6.00%)  3
fever in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10e9/L  2/50 (4.00%)  2
pain NOS  1/50 (2.00%)  1
Infections and infestations   
infection-other  1/50 (2.00%)  1
Investigations   
creatine  1/50 (2.00%)  1
Metabolism and nutrition disorders   
glucose, serum-low  1/50 (2.00%)  1
potassium, serum-low  1/50 (2.00%)  1
hyponatremia  1/50 (2.00%)  1
Musculoskeletal and connective tissue disorders   
hip fracture  3/50 (6.00%)  3
pain-right hip  1/50 (2.00%)  1
Nervous system disorders   
somnolence  1/50 (2.00%)  1
Renal and urinary disorders   
acute renal failure  1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
dyspnea  5/50 (10.00%)  5
hypoxia  2/50 (4.00%)  2
infection-documented with Grade 3 or 4 neutrophils-pneumonia  2/50 (4.00%)  2
infection with normal ANC or Grade 1 or 2 neutrophils-bronchus  1/50 (2.00%)  1
infection with normal ANC or Grade 1 or 2 neutrophils-lung  2/50 (4.00%)  2
infection with unknown ANC-lung  1/50 (2.00%)  1
pleural effusion  2/50 (4.00%)  2
pneumonitis/pulmonary infiltrates  1/50 (2.00%)  1
acute respiratory distress  1/50 (2.00%)  1
bilateral basilar pneumonia  1/50 (2.00%)  1
pulomonary emboli-multiple  1/50 (2.00%)  1
right lower lobe lung collapse  1/50 (2.00%)  1
hemoptysis  1/50 (2.00%)  1
pneumonia  4/50 (8.00%)  4
Vascular disorders   
clot, left upper arm  1/50 (2.00%)  1
superior vena cava syndrome  2/50 (4.00%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bendamustine
Affected / at Risk (%) # Events
Total   50/50 (100.00%)    
Blood and lymphatic system disorders   
hemoglobin  26/50 (52.00%)  49
leukocytes  11/50 (22.00%)  26
neutrophils/granulocytes  6/50 (12.00%)  9
platelets  17/50 (34.00%)  31
Gastrointestinal disorders   
constipation  9/50 (18.00%)  9
diarrhea  9/50 (18.00%)  13
gastrointestinal-other  3/50 (6.00%)  3
mucositis (functional/symptomatic)-oral cavity  3/50 (6.00%)  3
nausea  21/50 (42.00%)  24
pain-abdomen NOS  4/50 (8.00%)  4
vomiting  14/50 (28.00%)  19
General disorders   
constitutional symptoms-other  15/50 (30.00%)  51
edema-limb  4/50 (8.00%)  4
fatigue  25/50 (50.00%)  39
Investigations   
alkaline phosphatase  4/50 (8.00%)  5
Alanine aminotransferase, serum glutamic pyruvic transaminase (ALT, SGPT)  4/50 (8.00%)  5
aspartate transaminase, serum glutamic oxaloacetic transaminase (AST, SGOT)  6/50 (12.00%)  7
sodium, serum-low  9/50 (18.00%)  14
weight loss  10/50 (20.00%)  13
Metabolism and nutrition disorders   
albumin, serum-low  6/50 (12.00%)  7
anorexia  16/50 (32.00%)  20
calcium, serum-low  4/50 (8.00%)  4
glucose, serum-high  8/50 (16.00%)  15
magnesium, serum-low  5/50 (10.00%)  8
metabolic, laboratory-other  15/50 (30.00%)  31
potassium, serum-low  6/50 (12.00%)  9
Musculoskeletal and connective tissue disorders   
pain-back  7/50 (14.00%)  7
pain-extremity, limb  3/50 (6.00%)  3
pain-joint  6/50 (12.00%)  6
Nervous system disorders   
dizziness  5/50 (10.00%)  7
neurology-other  3/50 (6.00%)  3
neuropathy-sensory  3/50 (6.00%)  4
Psychiatric disorders   
insomnia  5/50 (10.00%)  5
depression  3/50 (6.00%)  3
Respiratory, thoracic and mediastinal disorders   
cough  8/50 (16.00%)  8
dyspnea  13/50 (26.00%)  13
pulmonary/upper respiratory-other  7/50 (14.00%)  11
Skin and subcutaneous tissue disorders   
dermatology/skin-other  5/50 (10.00%)  7
Vascular disorders   
hypotension  3/50 (6.00%)  3
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leora Horn, MD
Organization: Vanderbilt-Ingram Cancer Center
Phone: 615-936-2033
EMail: leora.horn@vanderbilt.edu
Layout table for additonal information
Responsible Party: Leora Horn, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00984542     History of Changes
Other Study ID Numbers: VICC THO 0920
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-THO-0920
First Submitted: September 24, 2009
First Posted: September 25, 2009
Results First Submitted: August 16, 2013
Results First Posted: March 12, 2014
Last Update Posted: March 12, 2014