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Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00284154
Recruitment Status : Completed
First Posted : January 31, 2006
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Small Cell
Lung Cancer
Intervention Drug: Vinflunine
Enrollment 51

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vinflunine
Hide Arm/Group Description Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
Period Title: Overall Study
Started 51
Completed 9
Not Completed 42
Arm/Group Title Vinflunine
Hide Arm/Group Description Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
<=18 years
0
   0.0%
Between 18 and 65 years
33
  64.7%
>=65 years
18
  35.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
61  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
23
  45.1%
Male
28
  54.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants
51
1.Primary Outcome
Title Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Hide Description Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were assessed for response.
Arm/Group Title Vinflunine
Hide Arm/Group Description:
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.6
(10 to 33)
2.Secondary Outcome
Title Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients’ Disease
Hide Description The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were assessed for response. Only patients with objective response were analyzed for response duration.
Arm/Group Title Vinflunine
Hide Arm/Group Description:
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: Months
2.7
(1.9 to 3.9)
3.Secondary Outcome
Title Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Hide Description Overall survival was measured from the date of study entry until the date of death.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were assessed for overall survival.
Arm/Group Title Vinflunine
Hide Arm/Group Description:
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: Months
4.9
(3.2 to 6.5)
4.Secondary Outcome
Title Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Hide Description Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were assessed for progression free survival.
Arm/Group Title Vinflunine
Hide Arm/Group Description:
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: Months
1.6
(1.3 to 3.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vinflunine
Hide Arm/Group Description Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
All-Cause Mortality
Vinflunine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vinflunine
Affected / at Risk (%) # Events
Total   31/51 (60.78%)    
Blood and lymphatic system disorders   
Hemoglobin  1  2/51 (3.92%)  2
Neutrophils  1  4/51 (7.84%)  4
Leukocytes  1  2/51 (3.92%)  2
Platelets  1  2/51 (3.92%)  2
Cardiac disorders   
Supraventricular and nodal arrhythmia - Atrial Fibrillation  1  1/51 (1.96%)  1
Endocrine disorders   
Pancreatic endocrine: glucose intolerance  1  1/51 (1.96%)  1
Gastrointestinal disorders   
Constipation  1  1/51 (1.96%)  1
Diarrhea  1  1/51 (1.96%)  1
Dysphagia  1  1/51 (1.96%)  1
Nausea  1  1/51 (1.96%)  1
Obstruction, GI - Small Bowel NOS  1  1/51 (1.96%)  1
Pain - abdomen  1  2/51 (3.92%)  2
General disorders   
Death not associated with CTCAE term - Disease Progression NOS  1  11/51 (21.57%)  11
Failure to thrive  1  1/51 (1.96%)  1
Fatigue  1  1/51 (1.96%)  1
Pain - Other (Pain Syndrome)  1  1/51 (1.96%)  1
Infections and infestations   
Febrile Neutropenia  1  2/51 (3.92%)  2
Infection - Other (Pneumonia)  1  2/51 (3.92%)  2
Metabolism and nutrition disorders   
Hyponatremia  1  1/51 (1.96%)  1
Hyperglycemia  1  1/51 (1.96%)  1
Musculoskeletal and connective tissue disorders   
Pain - joint  1  1/51 (1.96%)  1
Systemic lupus erythematosus  1  1/51 (1.96%)  1
Nervous system disorders   
Altered Mental Status  1  1/51 (1.96%)  1
Neuropathy  1  1/51 (1.96%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/51 (1.96%)  1
Pneumothorax  1  1/51 (1.96%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vinflunine
Affected / at Risk (%) # Events
Total   30/51 (58.82%)    
Blood and lymphatic system disorders   
Hemoglobin  1  28/51 (54.90%)  58
Edema  1  3/51 (5.88%)  3
Leukopenia  1  15/51 (29.41%)  30
Neutropenia  1  21/51 (41.18%)  47
Thrombocytopenia  1  11/51 (21.57%)  21
Cardiac disorders   
Hypertension  1  3/51 (5.88%)  5
Gastrointestinal disorders   
Anorexia  1  16/51 (31.37%)  30
Constipation  1  30/51 (58.82%)  53
Dehydration  1  5/51 (9.80%)  6
Diarrhea  1  12/51 (23.53%)  15
Mucositis  1  4/51 (7.84%)  11
Nausea  1  24/51 (47.06%)  39
Nausea (intermittent)  1  4/51 (7.84%)  7
Pain (abdominal)  1  6/51 (11.76%)  6
Vomiting  1  16/51 (31.37%)  23
Vomiting (intermittent)  1  3/51 (5.88%)  5
General disorders   
Fatigue  1  30/51 (58.82%)  71
Fever  1  7/51 (13.73%)  8
Insomnia  1  4/51 (7.84%)  8
Pain  1  3/51 (5.88%)  5
Weakness  1  10/51 (19.61%)  17
Weight Loss  1  7/51 (13.73%)  16
Metabolism and nutrition disorders   
AST  1  3/51 (5.88%)  4
Hyperglycemia  1  10/51 (19.61%)  25
Hypoalbuminemia  1  5/51 (9.80%)  8
Hypocalcemia  1  4/51 (7.84%)  4
Hypokalemia  1  4/51 (7.84%)  8
Hyponatremia  1  8/51 (15.69%)  15
Musculoskeletal and connective tissue disorders   
Pain (bone)  1  3/51 (5.88%)  3
Pain (jaw)  1  4/51 (7.84%)  4
Nervous system disorders   
Neuropathy (sensory)  1  3/51 (5.88%)  4
Pain (headache)  1  3/51 (5.88%)  5
Respiratory, thoracic and mediastinal disorders   
Cough  1  8/51 (15.69%)  13
Dyspnea  1  19/51 (37.25%)  31
Pain (chest)  1  3/51 (5.88%)  5
Sore throat  1  3/51 (5.88%)  3
Skin and subcutaneous tissue disorders   
Alopecia  1  7/51 (13.73%)  14
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Name/Title: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00284154     History of Changes
Other Study ID Numbers: SCRI LUN 122
First Submitted: January 27, 2006
First Posted: January 31, 2006
Results First Submitted: February 8, 2013
Results First Posted: March 13, 2013
Last Update Posted: March 13, 2013