Trial Outcomes & Findings for Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer (NCT NCT00284154)
NCT ID: NCT00284154
Last Updated: 2013-03-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
18 months
Results posted on
2013-03-13
Participant Flow
Participant milestones
| Measure |
Vinflunine
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Vinflunine
n=51 Participants
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age Continuous
|
61 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for response.
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.
Outcome measures
| Measure |
Vinflunine
n=51 Participants
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
|
|---|---|
|
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
19.6 percentage of participants
Interval 10.0 to 33.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for response. Only patients with objective response were analyzed for response duration.
The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
Outcome measures
| Measure |
Vinflunine
n=10 Participants
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
|
|---|---|
|
Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease
|
2.7 Months
Interval 1.9 to 3.9
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for overall survival.
Overall survival was measured from the date of study entry until the date of death.
Outcome measures
| Measure |
Vinflunine
n=51 Participants
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
|
|---|---|
|
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
|
4.9 Months
Interval 3.2 to 6.5
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for progression free survival.
Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
Outcome measures
| Measure |
Vinflunine
n=51 Participants
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
|
|---|---|
|
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
|
1.6 Months
Interval 1.3 to 3.9
|
Adverse Events
Vinflunine
Serious events: 31 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vinflunine
n=51 participants at risk
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term - Disease Progression NOS
|
21.6%
11/51 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/51 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Failure to thrive
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Fatigue
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Febrile Neutropenia
|
3.9%
2/51 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.9%
2/51 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Infection - Other (Pneumonia)
|
3.9%
2/51 • Number of events 2
|
|
Nervous system disorders
Altered Mental Status
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/51 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
2.0%
1/51 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils
|
7.8%
4/51 • Number of events 4
|
|
Gastrointestinal disorders
Obstruction, GI - Small Bowel NOS
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Pain - abdomen
|
3.9%
2/51 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain - joint
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Pain - Other (Pain Syndrome)
|
2.0%
1/51 • Number of events 1
|
|
Endocrine disorders
Pancreatic endocrine: glucose intolerance
|
2.0%
1/51 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/51 • Number of events 1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial Fibrillation
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.0%
1/51 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/51 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes
|
3.9%
2/51 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
3.9%
2/51 • Number of events 2
|
Other adverse events
| Measure |
Vinflunine
n=51 participants at risk
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.7%
7/51 • Number of events 14
|
|
Blood and lymphatic system disorders
Hemoglobin
|
54.9%
28/51 • Number of events 58
|
|
Gastrointestinal disorders
Anorexia
|
31.4%
16/51 • Number of events 30
|
|
Metabolism and nutrition disorders
AST
|
5.9%
3/51 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
58.8%
30/51 • Number of events 53
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.7%
8/51 • Number of events 13
|
|
Gastrointestinal disorders
Dehydration
|
9.8%
5/51 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
12/51 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.3%
19/51 • Number of events 31
|
|
Blood and lymphatic system disorders
Edema
|
5.9%
3/51 • Number of events 3
|
|
General disorders
Fatigue
|
58.8%
30/51 • Number of events 71
|
|
General disorders
Fever
|
13.7%
7/51 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.6%
10/51 • Number of events 25
|
|
Cardiac disorders
Hypertension
|
5.9%
3/51 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.8%
5/51 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.8%
4/51 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.8%
4/51 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.7%
8/51 • Number of events 15
|
|
General disorders
Insomnia
|
7.8%
4/51 • Number of events 8
|
|
Blood and lymphatic system disorders
Leukopenia
|
29.4%
15/51 • Number of events 30
|
|
Gastrointestinal disorders
Mucositis
|
7.8%
4/51 • Number of events 11
|
|
Gastrointestinal disorders
Nausea
|
47.1%
24/51 • Number of events 39
|
|
Gastrointestinal disorders
Nausea (intermittent)
|
7.8%
4/51 • Number of events 7
|
|
Nervous system disorders
Neuropathy (sensory)
|
5.9%
3/51 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
41.2%
21/51 • Number of events 47
|
|
General disorders
Pain
|
5.9%
3/51 • Number of events 5
|
|
Gastrointestinal disorders
Pain (abdominal)
|
11.8%
6/51 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Pain (bone)
|
5.9%
3/51 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pain (chest)
|
5.9%
3/51 • Number of events 5
|
|
Nervous system disorders
Pain (headache)
|
5.9%
3/51 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain (jaw)
|
7.8%
4/51 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.9%
3/51 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.6%
11/51 • Number of events 21
|
|
Gastrointestinal disorders
Vomiting
|
31.4%
16/51 • Number of events 23
|
|
Gastrointestinal disorders
Vomiting (intermittent)
|
5.9%
3/51 • Number of events 5
|
|
General disorders
Weakness
|
19.6%
10/51 • Number of events 17
|
|
General disorders
Weight Loss
|
13.7%
7/51 • Number of events 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER