Trial Outcomes & Findings for A Phase II Safety and Tolerability Study of Bevacizumab When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain (NCT NCT00476827)
NCT ID: NCT00476827
Last Updated: 2013-07-17
Results Overview
Primary endpoint has not been analysed secondary to slow and low accrual numbers.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
May 2009
Results posted on
2013-07-17
Participant Flow
Subjects will be identified in cancer center outpatient clinics multi-site. The study will be introduced by a physician or caregiver known to the patient. We will need to review protected health information in order to identify subjects, and information resulting from this activity will be used only to assess eligibility of a subject.
to meet inclusion must be 2 wks from prior hormonal chemotherapy and radio-static surgery, 4 weeks since major surgery and 8 weeks from neuro surgery. excluded for prior tx with avastin or other anti-angiogenic therapy. Central Nervous system hemorrhage
Participant milestones
| Measure |
Bevacizumab / Capecitabine
Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
|
Bevacizumab / Docetaxel
Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
|
Bevacizumab / Irinotecan (Camptosar®, CPT-11)
CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
|
Bevacizumab / Paclitaxel
Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
|
Bevacizumab /Vinorelbine Tartrate
Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
|
Bevacizumab / Gemcitabine
Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
1
|
0
|
2
|
2
|
|
Overall Study
COMPLETED
|
3
|
0
|
1
|
0
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Safety and Tolerability Study of Bevacizumab When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain
Baseline characteristics by cohort
| Measure |
Bevacizumab / Capecitabine
n=3 Participants
Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
|
Bevacizumab / Docetaxel
Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
|
Bevacizumab / CPT-11
n=1 Participants
CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
|
Bevacizumab / Paclitaxel
Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
|
Bevacizumab /Vinorelbine Tartrate
n=2 Participants
Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
|
Bevacizumab / Gemcitabine
n=2 Participants
Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
|
Age Categorical
Between 18 and 65 years
|
3 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
—
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
8 participants
n=8 Participants
|
|
Age Categorical
>=65 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
|
Age Continuous
|
48.3 years
STANDARD_DEVIATION NA • n=5 Participants
|
—
|
42 years
STANDARD_DEVIATION NA • n=5 Participants
|
—
|
52.5 years
STANDARD_DEVIATION NA • n=21 Participants
|
56.5 years
STANDARD_DEVIATION NA • n=8 Participants
|
50.6 years
STANDARD_DEVIATION 5.8 • n=8 Participants
|
|
Gender
Female
|
3 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
—
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
8 participants
n=8 Participants
|
|
Gender
Male
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
—
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: May 2009Population: Endpoint has not been analysed secondary to slow and low accrual numbers.
Primary endpoint has not been analysed secondary to slow and low accrual numbers.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: trial closurePopulation: Due to slow accrual study was prematurely closed and endpoint not analysed
Due to slow accrual study was prematurely closed and endpoint not analysed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 to 9 weeksPopulation: Due to slow accrual study was prematurely closed and endpoint not analysed
Due to slow accrual study was prematurely closed and endpoint not analysed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 to 9 weeksDue to slow accrual study was prematurely closed and endpoint not analysed
Outcome measures
Outcome data not reported
Adverse Events
Avastin (Bevacizumab)/ Capecitabine (Xeloda)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Avastin (Bevacizumab) / Camptosar (CPT 11/ Irinotecan)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Avastin (Bevacizumab)/Gemzar(Gemcitabine,Difluorodeoxycytidine
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Avastin (Bevacizumab)/Navelbine (Vinorelbine Tartrate)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Avastin (Bevacizumab)/ Capecitabine (Xeloda)
n=3 participants at risk
|
Avastin (Bevacizumab) / Camptosar (CPT 11/ Irinotecan)
n=1 participants at risk
|
Avastin (Bevacizumab)/Gemzar(Gemcitabine,Difluorodeoxycytidine
n=2 participants at risk
|
Avastin (Bevacizumab)/Navelbine (Vinorelbine Tartrate)
n=2 participants at risk
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
dehydration
|
33.3%
1/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
renal failure
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
hypophophatemia
|
0.00%
0/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Investigations
hypokalemia
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
Other adverse events
| Measure |
Avastin (Bevacizumab)/ Capecitabine (Xeloda)
n=3 participants at risk
|
Avastin (Bevacizumab) / Camptosar (CPT 11/ Irinotecan)
n=1 participants at risk
|
Avastin (Bevacizumab)/Gemzar(Gemcitabine,Difluorodeoxycytidine
n=2 participants at risk
|
Avastin (Bevacizumab)/Navelbine (Vinorelbine Tartrate)
n=2 participants at risk
|
|---|---|---|---|---|
|
Hepatobiliary disorders
ALT: increased
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
General disorders
anorexia
|
66.7%
2/3
|
100.0%
1/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Hepatobiliary disorders
AST: elevated
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
Ataxia
|
66.7%
2/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Investigations
Calcium: elevated
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Cardiac disorders
heart flutter
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
constipation
|
66.7%
2/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
100.0%
1/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
mouth tenderness
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
50.0%
1/2
|
|
Investigations
Creatinine:elevated
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
dehydration
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
dry skin
|
66.7%
2/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
diarrhea
|
66.7%
2/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
dizziness
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/3
|
100.0%
1/1
|
50.0%
1/2
|
0.00%
0/2
|
|
General disorders
edema: limb
|
33.3%
1/3
|
0.00%
0/1
|
50.0%
1/2
|
50.0%
1/2
|
|
General disorders
fatigue
|
100.0%
3/3
|
100.0%
1/1
|
50.0%
1/2
|
100.0%
2/2
|
|
General disorders
Flushing
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
hair loss
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
heart burn
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/2
|
50.0%
1/2
|
|
Blood and lymphatic system disorders
hemaglobin
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
50.0%
1/2
|
|
Blood and lymphatic system disorders
nose bleeds
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
50.0%
1/2
|
|
Gastrointestinal disorders
hemorrhoids
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
hot flashes
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
General disorders
Insomnia
|
66.7%
2/3
|
100.0%
1/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
leukocytes
|
0.00%
0/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
libido
|
0.00%
0/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Psychiatric disorders
memory impairment
|
66.7%
2/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Investigations
hypokalemia
|
33.3%
1/3
|
100.0%
1/1
|
50.0%
1/2
|
50.0%
1/2
|
|
Psychiatric disorders
irritability
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Psychiatric disorders
depression
|
33.3%
1/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
stomatitis
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/2
|
50.0%
1/2
|
|
Gastrointestinal disorders
nausea
|
100.0%
3/3
|
100.0%
1/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Nervous system disorders
neuropathy sensory
|
66.7%
2/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
neutrophils
|
66.7%
2/3
|
0.00%
0/1
|
100.0%
2/2
|
0.00%
0/2
|
|
Eye disorders
peripheral vision changes
|
33.3%
1/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
blindness
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
Pain: shingles
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
Pain: Shoulder and back
|
66.7%
2/3
|
100.0%
1/1
|
50.0%
1/2
|
0.00%
0/2
|
|
General disorders
Pain: breast
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
50.0%
1/2
|
|
Musculoskeletal and connective tissue disorders
Pain: extremity
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
headache
|
33.3%
1/3
|
0.00%
0/1
|
100.0%
1/1
|
50.0%
1/2
|
|
Eye disorders
blurred vision
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Eye disorders
visual floaters
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/2
|
50.0%
1/2
|
|
General disorders
voice changes
|
0.00%
0/3
|
0.00%
0/1
|
50.0%
1/2
|
50.0%
1/2
|
|
Gastrointestinal disorders
vomiting
|
100.0%
3/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Gastrointestinal disorders
weight gain
|
33.3%
1/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
33.3%
1/3
|
100.0%
1/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Investigations
phosphorus low
|
0.00%
0/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
General disorders
sore throat
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
rash
|
33.3%
1/3
|
100.0%
1/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
hand foot syndrome
|
100.0%
3/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Renal and urinary disorders
renal failure
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
chills/rigors
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
50.0%
1/2
|
|
Nervous system disorders
seizure
|
0.00%
0/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
skin breakdown
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/2
|
50.0%
1/2
|
|
Gastrointestinal disorders
taste changes
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
cerebral thrombosis
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
DVT
|
0.00%
0/3
|
0.00%
0/1
|
50.0%
1/2
|
0.00%
0/2
|
|
Ear and labyrinth disorders
tinnitus
|
33.3%
1/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Nervous system disorders
tremors
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/2
|
50.0%
1/2
|
|
Investigations
BUN elevated
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
vaginal dryness
|
33.3%
1/3
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
|
General disorders
weight loss
|
33.3%
1/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
dry mouth
|
0.00%
0/3
|
100.0%
1/1
|
0.00%
0/2
|
0.00%
0/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place