Trial Outcomes & Findings for Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer (NCT NCT00066677)
NCT ID: NCT00066677
Last Updated: 2021-03-05
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
4 months
Results posted on
2021-03-05
Participant Flow
Study was conducted at Fox Chase Cancer Center between October 2004 and December 20006.
Participant milestones
| Measure |
rhuMAB-VEGF
rhuMAB-VEGF :
|
rhuMAB-VEGF and Docetaxel
rhuMAB-VEGF :
docetaxel :
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
rhuMAB-VEGF
n=16 Participants
rhuMAB-VEGF :
|
rhuMAB-VEGF and Docetaxel
n=16 Participants
rhuMAB-VEGF :
docetaxel :
|
Total
n=32 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
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: The study was stopped according to the early stopping rule for futility. All patients who entered the study have died.
Outcome measures
| Measure |
rhuMAB-VEGF
n=16 Participants
rhuMAB-VEGF :
|
rhuMAB-VEGF and Docetaxel
n=16 Participants
rhuMAB-VEGF :
docetaxel :
|
|---|---|---|
|
Progression-free Survival
|
43 days
Interval 28.0 to 120.0
|
48 days
Interval 28.0 to 120.0
|
SECONDARY outcome
Timeframe: 56 daysOutcome measures
| Measure |
rhuMAB-VEGF
n=16 Participants
rhuMAB-VEGF :
|
rhuMAB-VEGF and Docetaxel
n=16 Participants
rhuMAB-VEGF :
docetaxel :
|
|---|---|---|
|
Objective Response Rate
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From date of registration until the date of death, assessed up to 5 yearsPopulation: The study was stopped according to the early stopping rule for futility. None of the patients survived.
Outcome measures
| Measure |
rhuMAB-VEGF
n=16 Participants
rhuMAB-VEGF :
|
rhuMAB-VEGF and Docetaxel
n=16 Participants
rhuMAB-VEGF :
docetaxel :
|
|---|---|---|
|
Overall Survival
|
165 days
Interval 28.0 to 480.0
|
125 days
Interval 28.0 to 480.0
|
SECONDARY outcome
Timeframe: 93 daysOutcome measures
| Measure |
rhuMAB-VEGF
n=16 Participants
rhuMAB-VEGF :
|
rhuMAB-VEGF and Docetaxel
n=16 Participants
rhuMAB-VEGF :
docetaxel :
|
|---|---|---|
|
Number of Participants With Thromboembolic Events
|
3 participants
|
2 participants
|
Adverse Events
rhuMAB-VEGF
Serious events: 13 serious events
Other events: 0 other events
Deaths: 16 deaths
rhuMAB-VEGF and Docetaxel
Serious events: 15 serious events
Other events: 0 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
rhuMAB-VEGF
n=16 participants at risk
rhuMAB-VEGF :
|
rhuMAB-VEGF and Docetaxel
n=16 participants at risk
rhuMAB-VEGF :
docetaxel :
|
|---|---|---|
|
General disorders
Anorexia
|
62.5%
10/16 • 2 years
|
68.8%
11/16 • 2 years
|
|
General disorders
Cholangitis
|
0.00%
0/16 • 2 years
|
12.5%
2/16 • 2 years
|
|
General disorders
Dehydration
|
18.8%
3/16 • 2 years
|
25.0%
4/16 • 2 years
|
|
General disorders
diarrhea
|
18.8%
3/16 • 2 years
|
25.0%
4/16 • 2 years
|
|
General disorders
DVT/pulmonary embolism
|
12.5%
2/16 • 2 years
|
12.5%
2/16 • 2 years
|
|
General disorders
Dysgeusia
|
0.00%
0/16 • 2 years
|
18.8%
3/16 • 2 years
|
|
General disorders
Fatigue
|
81.2%
13/16 • 2 years
|
93.8%
15/16 • 2 years
|
|
Gastrointestinal disorders
GI Bleeding
|
6.2%
1/16 • 2 years
|
12.5%
2/16 • 2 years
|
|
General disorders
Hyperkalemia
|
6.2%
1/16 • 2 years
|
12.5%
2/16 • 2 years
|
|
General disorders
Hyperuricemia
|
12.5%
2/16 • 2 years
|
0.00%
0/16 • 2 years
|
|
General disorders
Hypoalbuminemia
|
56.2%
9/16 • 2 years
|
62.5%
10/16 • 2 years
|
|
General disorders
Hypertension
|
18.8%
3/16 • 2 years
|
6.2%
1/16 • 2 years
|
|
General disorders
Injection site reaction
|
0.00%
0/16 • 2 years
|
12.5%
2/16 • 2 years
|
|
General disorders
Nail Changes
|
0.00%
0/16 • 2 years
|
25.0%
4/16 • 2 years
|
|
General disorders
Nausea and vomiting
|
43.8%
7/16 • 2 years
|
56.2%
9/16 • 2 years
|
|
General disorders
Parasthesias
|
0.00%
0/16 • 2 years
|
25.0%
4/16 • 2 years
|
|
General disorders
Perforation
|
0.00%
0/16 • 2 years
|
6.2%
1/16 • 2 years
|
|
General disorders
Peritonitis
|
6.2%
1/16 • 2 years
|
6.2%
1/16 • 2 years
|
|
General disorders
Proteinuria
|
37.5%
6/16 • 2 years
|
50.0%
8/16 • 2 years
|
|
General disorders
Watery eyes
|
0.00%
0/16 • 2 years
|
37.5%
6/16 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
12/16 • 2 years
|
93.8%
15/16 • 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
31.2%
5/16 • 2 years
|
68.8%
11/16 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
4/16 • 2 years
|
43.8%
7/16 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
2/16 • 2 years
|
18.8%
3/16 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place