Trial Outcomes & Findings for Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer (NCT NCT00740636)
NCT ID: NCT00740636
Last Updated: 2016-08-01
Results Overview
The objective response is defined as all complete responses and partial responses based on the modified RECIST.Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
2 years
Results posted on
2016-08-01
Participant Flow
Participant milestones
| Measure |
200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.
200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
|
75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.
75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
67
|
|
Overall Study
COMPLETED
|
23
|
63
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.
200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
|
75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.
75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Patient Ineligible
|
0
|
1
|
|
Overall Study
Patient Not Treated
|
0
|
1
|
|
Overall Study
Progressive Disease
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.
n=25 Participants
200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
|
75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.
n=67 Participants
75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe objective response is defined as all complete responses and partial responses based on the modified RECIST.Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.
n=23 Participants
200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
|
75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.
n=63 Participants
75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
|
|---|---|---|
|
The Objective Overall Response
Partial Response (PR)
|
7 participants
|
12 participants
|
|
The Objective Overall Response
Stable Disease (SD)
|
7 participants
|
19 participants
|
|
The Objective Overall Response
Progression of Disease (POD)
|
9 participants
|
31 participants
|
|
The Objective Overall Response
Complete Response (CR)
|
0 participants
|
1 participants
|
Adverse Events
200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.
Serious events: 12 serious events
Other events: 20 other events
Deaths: 0 deaths
75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.
Serious events: 20 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.
n=25 participants at risk
200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
|
75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.
n=67 participants at risk
75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
|
|---|---|---|
|
General disorders
Death not assoc w CTCAE term- Death NOS
|
4.0%
1/25 • Number of events 1
|
0.00%
0/67
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
12.0%
3/25 • Number of events 3
|
1.5%
1/67 • Number of events 1
|
|
General disorders
Dehydration
|
4.0%
1/25 • Number of events 1
|
0.00%
0/67
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 1
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
8.0%
2/25 • Number of events 2
|
3.0%
2/67 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
4.0%
1/25 • Number of events 1
|
4.5%
3/67 • Number of events 3
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Lung (pneumonia)
|
4.0%
1/25 • Number of events 1
|
0.00%
0/67
|
|
General disorders
Pain
|
12.0%
3/25 • Number of events 4
|
4.5%
3/67 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
4.0%
1/25 • Number of events 1
|
1.5%
1/67 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
4.0%
1/25 • Number of events 1
|
0.00%
0/67
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
8.0%
2/25 • Number of events 2
|
3.0%
2/67 • Number of events 2
|
|
General disorders
Somnolence/depressed level of conscious
|
4.0%
1/25 • Number of events 1
|
0.00%
0/67
|
|
Cardiac disorders
Thrombosis/thrombus/embolism
|
8.0%
2/25 • Number of events 2
|
0.00%
0/67
|
|
Blood and lymphatic system disorders
AST, SGOT
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/25
|
3.0%
2/67 • Number of events 2
|
|
Nervous system disorders
Confusion
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
General disorders
Edema: limb
|
0.00%
0/25
|
3.0%
2/67 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding, other
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
General disorders
Hypoxia
|
0.00%
0/25
|
3.0%
2/67 • Number of events 2
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Pneumonia(lung)
|
0.00%
0/25
|
3.0%
2/67 • Number of events 2
|
|
Infections and infestations
Infection unknown ANC-UTI NOS
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
Nervous system disorders
Neurology - Other
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
General disorders
Secondary malignancy possibly related to treatment
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
Metabolism and nutrition disorders
Secondary malig-poss related to ca txt specify
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
|
General disorders
Muscle weakness - Whole body/general
|
0.00%
0/25
|
1.5%
1/67 • Number of events 1
|
Other adverse events
| Measure |
200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.
n=25 participants at risk
200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
|
75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.
n=67 participants at risk
75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
20.0%
5/25 • Number of events 5
|
10.4%
7/67 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.0%
3/25 • Number of events 3
|
11.9%
8/67 • Number of events 11
|
|
Blood and lymphatic system disorders
ALT, SGPT
|
0.00%
0/25
|
6.0%
4/67 • Number of events 4
|
|
Blood and lymphatic system disorders
AST, SGOT
|
0.00%
0/25
|
6.0%
4/67 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25
|
9.0%
6/67 • Number of events 7
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
24.0%
6/25 • Number of events 8
|
31.3%
21/67 • Number of events 34
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
8.0%
2/25 • Number of events 2
|
20.9%
14/67 • Number of events 14
|
|
Blood and lymphatic system disorders
Hemoglobin
|
20.0%
5/25 • Number of events 5
|
25.4%
17/67 • Number of events 17
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
24.0%
6/25 • Number of events 6
|
0.00%
0/67
|
|
Blood and lymphatic system disorders
Lymphopenia
|
24.0%
6/25 • Number of events 6
|
38.8%
26/67 • Number of events 26
|
|
General disorders
Nausea
|
8.0%
2/25 • Number of events 4
|
13.4%
9/67 • Number of events 9
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
16.0%
4/25 • Number of events 4
|
0.00%
0/67
|
|
General disorders
Pain - Head/headache
|
8.0%
2/25 • Number of events 2
|
0.00%
0/67
|
|
General disorders
Pain - Other
|
8.0%
2/25 • Number of events 3
|
0.00%
0/67
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
8.0%
2/25 • Number of events 2
|
0.00%
0/67
|
|
Blood and lymphatic system disorders
Platelets
|
24.0%
6/25 • Number of events 6
|
7.5%
5/67 • Number of events 5
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
8.0%
2/25 • Number of events 2
|
11.9%
8/67 • Number of events 8
|
|
General disorders
Vomiting
|
8.0%
2/25 • Number of events 3
|
0.00%
0/67
|
Additional Information
Dr. Maria C. Pietanza
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place