Trial Outcomes & Findings for Brain Mets - Capecitabine Plus Sunitinib and WBRT (NCT NCT00570908)
NCT ID: NCT00570908
Last Updated: 2014-09-18
Results Overview
Progression free survival is defined as form initiation of WBRT with capecitabine to the time of first documented progression at any site (CNS or non-CNS site) or death due to any cause, where progression is defined stringently by progression in either CNS or extra-CNS metastases.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
2 years
Results posted on
2014-09-18
Participant Flow
Participant milestones
| Measure |
WBRT + Capecitabine + Sunitinib
capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
WBRT + Capecitabine + Sunitinib
capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Brain Mets - Capecitabine Plus Sunitinib and WBRT
Baseline characteristics by cohort
| Measure |
WBRT + Capecitabine + Sunitinib
n=12 Participants
capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
|
|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 5 patients progressed during the study treatment. 7 patients were off study treatment early due to AE or withdrawal but 6 of them were followed for the survival outcome, 1 was lost to follow up after 3.5 months observation (censored data).
Progression free survival is defined as form initiation of WBRT with capecitabine to the time of first documented progression at any site (CNS or non-CNS site) or death due to any cause, where progression is defined stringently by progression in either CNS or extra-CNS metastases.
Outcome measures
| Measure |
WBRT + Capecitabine + Sunitinib
n=12 Participants
capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
|
|---|---|
|
Progression Free Survival
|
4.7 months
Interval 2.1 to 7.1
|
Adverse Events
WBRT + Capecitabine + Sunitinib
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
WBRT + Capecitabine + Sunitinib
n=12 participants at risk
capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
|
|---|---|
|
Cardiac disorders
Cardiac - CHF
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (SOB)
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetetic Ketoacidosis
|
8.3%
1/12 • Number of events 1
|
Other adverse events
| Measure |
WBRT + Capecitabine + Sunitinib
n=12 participants at risk
capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
|
|---|---|
|
Metabolism and nutrition disorders
Alkaline Phosphate
|
25.0%
3/12 • Number of events 4
|
|
Metabolism and nutrition disorders
AST
|
50.0%
6/12 • Number of events 11
|
|
Metabolism and nutrition disorders
Bilirubin, Elevated
|
25.0%
3/12 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
Dehydration
|
25.0%
3/12 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12 • Number of events 3
|
|
General disorders
Fatifue
|
66.7%
8/12 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin Reaction
|
41.7%
5/12 • Number of events 7
|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
4/12 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
16.7%
2/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.7%
5/12 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
2/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Leukocytes
|
41.7%
5/12 • Number of events 7
|
|
Psychiatric disorders
Mood Alteration - Depression
|
25.0%
3/12 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis - Oral
|
50.0%
6/12 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
58.3%
7/12 • Number of events 8
|
|
Infections and infestations
Neutropenia
|
16.7%
2/12 • Number of events 2
|
|
Nervous system disorders
Pain - Headache
|
16.7%
2/12 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
6/12 • Number of events 10
|
|
Endocrine disorders
TSH
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
vomiting
|
16.7%
2/12 • Number of events 2
|
|
Metabolism and nutrition disorders
ALT
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
ANC low
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bilateral Pedal Edema
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Dry Mouth
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Dysgeusia
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema - Right Axillary
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
E. Coli Bacteremia
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Gums - Bleeding
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemolysis
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernaturia
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Infection - Middle Ear
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Infection - Sinus
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Oral Thrush
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
8.3%
1/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash - Leg
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Urinary Frequency
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Vision - Flashing Lights
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Low WBC
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Pain
|
50.0%
6/12 • Number of events 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place