Trial Outcomes & Findings for Chemoembolization and Bevacizumab in Treating Patients With Liver Cancer That Cannot Be Removed With Surgery (NCT NCT00049322)
NCT ID: NCT00049322
Last Updated: 2020-09-01
Results Overview
Angiograms were assessed for changes in vascularity. The numbers indicate how many subjects in each group showed neovessel formation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
14 weeks
Results posted on
2020-09-01
Participant Flow
date of recruitment period August 2003- October 2008. Types of location: Academic medical clinics and community medical clinics.
Participant milestones
| Measure |
Arm I (TACE-BEV Arm)
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.
|
Arm II (TACE-O Arm )
Observation
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Arm I (TACE-BEV Arm)
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.
|
Arm II (TACE-O Arm )
Observation
|
|---|---|---|
|
Overall Study
disease burden
|
0
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
refused angio
|
0
|
3
|
Baseline Characteristics
Chemoembolization and Bevacizumab in Treating Patients With Liver Cancer That Cannot Be Removed With Surgery
Baseline characteristics by cohort
| Measure |
Arm I (TACE-BEV Arm)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.
|
Arm II (TACE-O Arm )
n=15 Participants
Observation
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Median age
|
61 years
n=99 Participants
|
58 years
n=107 Participants
|
59.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 weeksAngiograms were assessed for changes in vascularity. The numbers indicate how many subjects in each group showed neovessel formation.
Outcome measures
| Measure |
Arm I (TACE-BEV Arm)
n=14 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.
|
Arm II (TACE-O Arm )
n=9 Participants
Observation
|
|---|---|---|
|
Neovessel Formation as Measured by Angiogram at 14 Weeks
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Arm I: Patients receive bevacizumab Arm II. Patients do not receive bevacizumab.
Progression free survival (PFS) at 16 weeks (end of the core phase).
Outcome measures
| Measure |
Arm I (TACE-BEV Arm)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.
|
Arm II (TACE-O Arm )
n=15 Participants
Observation
|
|---|---|---|
|
Progression Free Survival
|
.79 probablility of pfs at 16 weeks
|
.19 probablility of pfs at 16 weeks
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: subjects that completed all 16 weeks.
Outcome measures
| Measure |
Arm I (TACE-BEV Arm)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.
|
Arm II (TACE-O Arm )
n=14 Participants
Observation
|
|---|---|---|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
Anemia
|
3 participants
|
6 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
Anorexia
|
5 participants
|
4 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
Bleeding
|
8 participants
|
1 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
Constipation
|
4 participants
|
3 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
Electrolyte abnormalities
|
9 participants
|
9 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
Elevated alkaline phosphatase
|
4 participants
|
3 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
elevated transaminases
|
15 participants
|
14 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
fatigue
|
9 participants
|
8 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
hyperbilirubinemia
|
8 participants
|
7 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
hypertension
|
6 participants
|
4 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
hypoalbuminemia
|
5 participants
|
7 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
nausea and or vomiting
|
6 participants
|
9 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
pain
|
11 participants
|
13 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
proteinuria
|
8 participants
|
1 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
pyrexia
|
8 participants
|
7 participants
|
|
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
thrombocytopenia
|
7 participants
|
10 participants
|
SECONDARY outcome
Timeframe: day 85bevacizumab serum concentrations
Outcome measures
| Measure |
Arm I (TACE-BEV Arm)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.
|
Arm II (TACE-O Arm )
Observation
|
|---|---|---|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Peak Day 1
|
203 micrograms/mL
Interval 181.0 to 225.0
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Peak Day 15
|
237 micrograms/mL
Interval 211.0 to 263.0
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Trough Day 15
|
35.4 micrograms/mL
Interval 31.5 to 39.4
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Peak Day 29
|
297 micrograms/mL
Interval 268.0 to 325.0
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Trough Day 29
|
74.3 micrograms/mL
Interval 66.7 to 82.0
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Peak Day 43
|
280 micrograms/mL
Interval 232.0 to 328.0
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Trough Day 43
|
84.7 micrograms/mL
Interval 60.4 to 109.0
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Peak Day 57
|
272 micrograms/mL
Interval 231.0 to 313.0
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Trough Day 57
|
97.7 micrograms/mL
Interval 71.3 to 124.0
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Peak Day 85
|
333 micrograms/mL
Interval 300.0 to 366.0
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Trough Day 85
|
119 micrograms/mL
Interval 95.4 to 142.0
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Day 8
|
83.2 micrograms/mL
Interval 71.7 to 94.6
|
—
|
|
Assess Pharmakokinetics of Bevacizumab in Liver Disease
Day 11
|
60.9 micrograms/mL
Interval 53.2 to 68.6
|
—
|
SECONDARY outcome
Timeframe: 21 days after TACEOutcome measures
| Measure |
Arm I (TACE-BEV Arm)
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.
|
Arm II (TACE-O Arm )
Observation
|
|---|---|---|
|
Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab
1 hour
|
.053 fold change
|
—
|
|
Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab
24 hours
|
.167 fold change
|
—
|
|
Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab
48 hours
|
.161 fold change
|
—
|
|
Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab
72 hours
|
.048 fold change
|
—
|
|
Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab
360 hours
|
.039 fold change
|
—
|
|
Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab
528 hours
|
.063 fold change
|
—
|
|
Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab
696 hours
|
.06 fold change
|
—
|
Adverse Events
Arm I
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm II
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=15 participants at risk
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.
|
Arm II
n=14 participants at risk
Patients do not receive bevacizumab
|
|---|---|---|
|
Gastrointestinal disorders
GI bleed
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
|
Gastrointestinal disorders
Hematemesis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
|
Gastrointestinal disorders
Partial Small Bowel obstruction
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
|
Hepatobiliary disorders
Liver Failure
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
|
General disorders
altered mental status
|
6.7%
1/15 • Number of events 1
|
0.00%
0/14
|
Other adverse events
| Measure |
Arm I
n=15 participants at risk
Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.
Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.
|
Arm II
n=14 participants at risk
Patients do not receive bevacizumab
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
3/15 • Number of events 3
|
42.9%
6/14 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
5/15 • Number of events 5
|
28.6%
4/14 • Number of events 4
|
|
Vascular disorders
Bleeding
|
53.3%
8/15 • Number of events 8
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
26.7%
4/15 • Number of events 4
|
21.4%
3/14 • Number of events 3
|
|
Metabolism and nutrition disorders
Electrolyte Abnormalities
|
60.0%
9/15 • Number of events 9
|
64.3%
9/14 • Number of events 9
|
|
Hepatobiliary disorders
Elevated Alkaline Phosphatase
|
26.7%
4/15 • Number of events 4
|
21.4%
3/14 • Number of events 3
|
|
Hepatobiliary disorders
Elevated Transaminases
|
100.0%
15/15 • Number of events 15
|
100.0%
14/14 • Number of events 14
|
|
General disorders
Fatigue
|
60.0%
9/15 • Number of events 9
|
57.1%
8/14 • Number of events 8
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
53.3%
8/15 • Number of events 8
|
50.0%
7/14 • Number of events 7
|
|
Cardiac disorders
Hypertension
|
40.0%
6/15 • Number of events 6
|
28.6%
4/14 • Number of events 4
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
33.3%
5/15 • Number of events 5
|
50.0%
7/14 • Number of events 7
|
|
Gastrointestinal disorders
Nausea and or Vomiting
|
40.0%
6/15 • Number of events 6
|
64.3%
9/14 • Number of events 9
|
|
General disorders
Pain
|
73.3%
11/15 • Number of events 11
|
92.9%
13/14 • Number of events 13
|
|
Renal and urinary disorders
Proteinuria
|
53.3%
8/15 • Number of events 8
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pyrexia
|
53.3%
8/15 • Number of events 8
|
50.0%
7/14 • Number of events 7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
46.7%
7/15 • Number of events 7
|
71.4%
10/14 • Number of events 10
|
Additional Information
Carolyn Britten, M.D.
University of California Los Angeles
Phone: 310 829 4971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place