Trial Outcomes & Findings for Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer (NCT NCT00416494)
NCT ID: NCT00416494
Last Updated: 2014-09-03
Results Overview
Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression. Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. The definitions were: Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
COMPLETED
PHASE2
50 participants
After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.
2014-09-03
Participant Flow
Patients were recruited between September 2003 and July 2005 in the Duke Cancer Center and Duke Oncology Network sites.
Participant milestones
| Measure |
Initial Cohort
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
|
Second Cohort
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
31
|
|
Overall Study
COMPLETED
|
19
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Initial Cohort
n=19 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
|
Second Cohort
n=31 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
|
Total
n=50 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
|
14 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
55 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
31 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.Population: All subjects who had restaging scans were included in the analysis.
Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression. Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. The definitions were: Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Initial Cohort
n=19 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
|
Second Cohort
n=31 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
|
|---|---|---|
|
Response Rate (Percentage of Participants With Partial or Complete Response)
|
63 percentage of participants with response
Interval 38.0 to 84.0
|
42 percentage of participants with response
Interval 25.0 to 61.0
|
SECONDARY outcome
Timeframe: From time of treatment until documented progression, assesed up to 60 months.Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Initial Cohort
n=19 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
|
Second Cohort
n=31 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
|
|---|---|---|
|
Time to Progression
|
10.1 months
95% Confidence Interval 5.7 • Interval 5.7 to 19.5
|
10.4 months
Interval 6.9 to 15.4
|
SECONDARY outcome
Timeframe: From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Initial Cohort
n=19 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
|
Second Cohort
n=31 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
|
|---|---|---|
|
Disease Free Survival
|
10.1 months
Interval 5.7 to 19.5
|
10.4 months
Interval 6.9 to 15.4
|
SECONDARY outcome
Timeframe: From time of treatment until death from any cause, assesed up to 60 months.Average months of survival of participants after receiving study drug.
Outcome measures
| Measure |
Initial Cohort
n=19 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
|
Second Cohort
n=31 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
|
|---|---|---|
|
Overall Survival
|
19.6 months
Interval 13.3 to 30.2
|
24.8 months
Interval 12.9 to 39.7
|
SECONDARY outcome
Timeframe: After all participants went off study drug regimine.Number of participants with adverse events
Outcome measures
| Measure |
Initial Cohort
n=19 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
|
Second Cohort
n=31 Participants
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
|
|---|---|---|
|
Safety and Tolerability
|
19 participants with adverse event
|
29 participants with adverse event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After study completionOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: After study completionOutcome measures
Outcome data not reported
Adverse Events
Initial Cohort
Second Cohort
Serious adverse events
| Measure |
Initial Cohort
n=19 participants at risk
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
|
Second Cohort
n=31 participants at risk
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
|
|---|---|---|
|
Gastrointestinal disorders
Bowel Perforation
|
5.3%
1/19 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Acute Calculus Cholecystitis
|
5.3%
1/19 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Wound Dehisence
|
5.3%
1/19 • Number of events 1
|
0.00%
0/31
|
|
Cardiac disorders
Congestive Heart Failure
|
5.3%
1/19 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Seizure
|
0.00%
0/19
|
3.2%
1/31 • Number of events 1
|
|
Vascular disorders
Syncope
|
0.00%
0/19
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Altered mental status
|
5.3%
1/19 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/19
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/19
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
Angina
|
0.00%
0/19
|
3.2%
1/31 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/19
|
3.2%
1/31 • Number of events 1
|
Other adverse events
| Measure |
Initial Cohort
n=19 participants at risk
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
|
Second Cohort
n=31 participants at risk
oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.
bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1
Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
|
|---|---|---|
|
Gastrointestinal disorders
Anorexia
|
78.9%
15/19 • Number of events 15
|
54.8%
17/31 • Number of events 17
|
|
Gastrointestinal disorders
Abdominal Cramping
|
42.1%
8/19 • Number of events 8
|
38.7%
12/31 • Number of events 12
|
|
Immune system disorders
Allergic reaction
|
5.3%
1/19 • Number of events 1
|
0.00%
0/31
|
|
General disorders
Chills
|
10.5%
2/19 • Number of events 2
|
12.9%
4/31 • Number of events 4
|
|
Investigations
Neutropenia
|
21.1%
4/19 • Number of events 4
|
6.5%
2/31 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
57.9%
11/19 • Number of events 11
|
38.7%
12/31 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.4%
9/19 • Number of events 9
|
32.3%
10/31 • Number of events 10
|
|
Gastrointestinal disorders
Dehydration
|
10.5%
2/19 • Number of events 2
|
9.7%
3/31 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
84.2%
16/19 • Number of events 16
|
64.5%
20/31 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Edema
|
0.00%
0/19
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Fatigue
|
84.2%
16/19 • Number of events 16
|
74.2%
23/31 • Number of events 23
|
|
General disorders
Fever
|
21.1%
4/19 • Number of events 4
|
9.7%
3/31 • Number of events 3
|
|
Gastrointestinal disorders
Flatuance
|
0.00%
0/19
|
9.7%
3/31 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
78.9%
15/19 • Number of events 15
|
35.5%
11/31 • Number of events 11
|
|
Vascular disorders
Hypertension
|
10.5%
2/19 • Number of events 2
|
12.9%
4/31 • Number of events 4
|
|
Vascular disorders
Hypotension
|
0.00%
0/19
|
9.7%
3/31 • Number of events 3
|
|
Infections and infestations
Infection
|
21.1%
4/19 • Number of events 4
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Insomnia
|
63.2%
12/19 • Number of events 12
|
38.7%
12/31 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
73.7%
14/19 • Number of events 14
|
51.6%
16/31 • Number of events 16
|
|
General disorders
Pain
|
68.4%
13/19 • Number of events 13
|
64.5%
20/31 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
73.7%
14/19 • Number of events 14
|
51.6%
16/31 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
31.6%
6/19 • Number of events 6
|
25.8%
8/31 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
42.1%
8/19 • Number of events 8
|
41.9%
13/31 • Number of events 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place