Trial Outcomes & Findings for Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases (NCT NCT00026494)
NCT ID: NCT00026494
Last Updated: 2016-01-18
Results Overview
All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
2 years
Results posted on
2016-01-18
Participant Flow
Participant milestones
| Measure |
15mg/m2 - Vinorelbine
Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
20mg/m2 - Vinorelbine
Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
25mg/m2 - Vinorelbine
Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
30mg/m2 - Vinorelbine
Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
22
|
16
|
|
Overall Study
COMPLETED
|
5
|
4
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
6
|
0
|
Reasons for withdrawal
| Measure |
15mg/m2 - Vinorelbine
Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
20mg/m2 - Vinorelbine
Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
25mg/m2 - Vinorelbine
Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
30mg/m2 - Vinorelbine
Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Patient non-compliance
|
1
|
0
|
0
|
0
|
|
Overall Study
Patient not treated
|
0
|
0
|
2
|
0
|
|
Overall Study
Clinical progression
|
0
|
0
|
3
|
0
|
Baseline Characteristics
Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases
Baseline characteristics by cohort
| Measure |
15mg/m2 - Vinorelbine
n=7 Participants
Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
20mg/m2 - Vinorelbine
n=4 Participants
Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
25mg/m2 - Vinorelbine
n=22 Participants
Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
30mg/m2 - Vinorelbine
n=16 Participants
Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
Total
n=49 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 yearsAll patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions.
Outcome measures
| Measure |
15mg/m2 - Vinorelbine
n=5 Participants
Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
20mg/m2 - Vinorelbine
n=4 Participants
Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
25mg/m2 - Vinorelbine
n=16 Participants
Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
30mg/m2 - Vinorelbine
n=16 Participants
Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
|---|---|---|---|---|
|
Radiographic Response Assessed by Macdonald Criteria Every 2 Months
Stable Disease (SD)
|
3 participants
|
2 participants
|
4 participants
|
3 participants
|
|
Radiographic Response Assessed by Macdonald Criteria Every 2 Months
Progression of Disease (POD)
|
2 participants
|
1 participants
|
11 participants
|
12 participants
|
|
Radiographic Response Assessed by Macdonald Criteria Every 2 Months
Partial Response (PR)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Radiographic Response Assessed by Macdonald Criteria Every 2 Months
Minor Response (MR)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Radiographic Response Assessed by Macdonald Criteria Every 2 Months
Complete Response (CR)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
15mg/m2 - Vinorelbine
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
20mg/m2 - Vinorelbine
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
25mg/m2 - Vinorelbine
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
30mg/m2 - Vinorelbine
Serious events: 9 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
15mg/m2 - Vinorelbine
n=7 participants at risk
Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
20mg/m2 - Vinorelbine
n=4 participants at risk
Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
25mg/m2 - Vinorelbine
n=22 participants at risk
Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
30mg/m2 - Vinorelbine
n=16 participants at risk
Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
|---|---|---|---|---|
|
Nervous system disorders
Confusion
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
9.1%
2/22 • Number of events 2
|
0.00%
0/16
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/22
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Neutrophils
|
14.3%
1/7 • Number of events 1
|
25.0%
1/4 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
25.0%
4/16 • Number of events 7
|
|
Cardiac disorders
Supravent arrhythmia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/22
|
0.00%
0/16
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/22
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.00%
0/7
|
25.0%
1/4 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
25.0%
4/16 • Number of events 7
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/22
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/7
|
50.0%
2/4 • Number of events 2
|
4.5%
1/22 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Seizure
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
6.2%
1/16 • Number of events 2
|
|
General disorders
Syncope
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Anorexia
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Hematuria
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
0.00%
0/16
|
|
Psychiatric disorders
Mood alteration-depression
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Muscle weakness
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Neurology, other
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Neuropathy-motor
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Speech Impair
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Ataxia
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
CNS hemorrhage
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Constitut symptoms, other
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Headache
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin (Hgb)
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Syndromes, other
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
15mg/m2 - Vinorelbine
n=7 participants at risk
Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
20mg/m2 - Vinorelbine
n=4 participants at risk
Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
25mg/m2 - Vinorelbine
n=22 participants at risk
Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
30mg/m2 - Vinorelbine
n=16 participants at risk
Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/7
|
0.00%
0/4
|
13.6%
3/22 • Number of events 3
|
18.8%
3/16 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
2/7 • Number of events 2
|
0.00%
0/4
|
22.7%
5/22 • Number of events 5
|
31.2%
5/16 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/7
|
0.00%
0/4
|
13.6%
3/22 • Number of events 3
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/22
|
25.0%
4/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
28.6%
2/7 • Number of events 2
|
0.00%
0/4
|
13.6%
3/22 • Number of events 3
|
31.2%
5/16 • Number of events 5
|
|
General disorders
Incontinence
|
0.00%
0/7
|
0.00%
0/4
|
13.6%
3/22 • Number of events 3
|
0.00%
0/16
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
71.4%
5/7 • Number of events 5
|
50.0%
2/4 • Number of events 2
|
50.0%
11/22 • Number of events 11
|
75.0%
12/16 • Number of events 12
|
|
Psychiatric disorders
Mood alteration-depression
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Nausea
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Neurology, other
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
|
Nervous system disorders
Neuropathy-motor
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils
|
28.6%
2/7 • Number of events 2
|
50.0%
2/4 • Number of events 2
|
40.9%
9/22 • Number of events 9
|
68.8%
11/16 • Number of events 11
|
|
Eye disorders
Ocular-Vision other
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Pain, other
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
2/22 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Pelvic pain
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
14.3%
1/7 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
25.0%
4/16 • Number of events 4
|
|
Blood and lymphatic system disorders
Prothrombin time (PT)
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
2/22 • Number of events 2
|
18.8%
3/16 • Number of events 3
|
|
Blood and lymphatic system disorders
Partial thromboplastin time (PTT)
|
0.00%
0/7
|
0.00%
0/4
|
22.7%
5/22 • Number of events 5
|
25.0%
4/16 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash, desquamation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/22
|
0.00%
0/16
|
|
Nervous system disorders
Seizure
|
0.00%
0/7
|
0.00%
0/4
|
9.1%
2/22 • Number of events 2
|
18.8%
3/16 • Number of events 3
|
|
Blood and lymphatic system disorders
SGOT (AST)
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
9.1%
2/22 • Number of events 2
|
25.0%
4/16 • Number of events 4
|
|
Blood and lymphatic system disorders
SGPT (ALT)
|
14.3%
1/7 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
22.7%
5/22 • Number of events 5
|
37.5%
6/16 • Number of events 6
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Insomnia
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes
|
42.9%
3/7 • Number of events 3
|
75.0%
3/4 • Number of events 3
|
54.5%
12/22 • Number of events 12
|
81.2%
13/16 • Number of events 13
|
|
General disorders
Abdominal pain/cramping
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
13.6%
3/22 • Number of events 3
|
18.8%
3/16 • Number of events 3
|
|
General disorders
Anorexia
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Bicarbonate
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/22
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Bilirubin
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood,Bone marrow,other
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Chest pain
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
CNS hemorrhage
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology, skin other
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
25.0%
4/16 • Number of events 4
|
|
General disorders
Headache
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/22
|
18.8%
3/16 • Number of events 3
|
|
General disorders
Hearing, other
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin (Hgb)
|
28.6%
2/7 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
40.9%
9/22 • Number of events 9
|
56.2%
9/16 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/7
|
0.00%
0/4
|
4.5%
1/22 • Number of events 1
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
57.1%
4/7 • Number of events 4
|
50.0%
2/4 • Number of events 2
|
50.0%
11/22 • Number of events 11
|
56.2%
9/16 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesmia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/22
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/22
|
6.2%
1/16 • Number of events 1
|
Additional Information
Dr. Lisa Deangelis
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7997
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place