Trial Outcomes & Findings for A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum (NCT NCT02582970)
NCT ID: NCT02582970
Last Updated: 2017-03-09
Results Overview
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.
COMPLETED
PHASE4
40 participants
Baseline up to approximately 3 years
2017-03-09
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Chemotherapy
Participants received bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks (q2w) in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum
Baseline characteristics by cohort
| Measure |
Bevacizumab + Chemotherapy
n=40 Participants
Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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|---|---|
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Age, Continuous
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58.6 years
STANDARD_DEVIATION 13.18 • n=5 Participants
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Sex: Female, Male
Female
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15 Participants
n=5 Participants
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Sex: Female, Male
Male
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25 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline up to approximately 3 yearsPopulation: ITT population.
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=40 Participants
Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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|---|---|
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Percentage of Participants With Adverse Events
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100 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to approximately 3 yearsPopulation: ITT population.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=40 Participants
Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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|---|---|
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Percentage of Participants Who Died
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62.5 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to approximately 3 yearsPopulation: ITT population.
Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=40 Participants
Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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|---|---|
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Duration of Survival
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23.8 months
Interval 13.7 to 27.2
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SECONDARY outcome
Timeframe: Baseline up to approximately 3 yearsPopulation: ITT population.
Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL).
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=40 Participants
Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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|---|---|
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Percentage of Participants With Disease Progression or Death
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85.0 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to approximately 3 yearsPopulation: ITT population.
Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=40 Participants
Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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|---|---|
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Progression-Free Survival Time
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12.2 months
Interval 9.4 to 15.9
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SECONDARY outcome
Timeframe: Baseline up to approximately 3 yearsPopulation: ITT population.
The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=40 Participants
Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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|---|---|
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Number of Participants With Best Overall Response
CR
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2 participants
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Number of Participants With Best Overall Response
PR
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19 participants
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Number of Participants With Best Overall Response
PD
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8 participants
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Number of Participants With Best Overall Response
SD
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9 participants
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Number of Participants With Best Overall Response
Missing
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2 participants
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SECONDARY outcome
Timeframe: Baseline up to approximately 3 yearsPopulation: ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Number Analyzed = participants who were evaluable for specified categories of this outcome measure.
Direct medical cost included cost of out-patient consultation and cost of hospitalization.
Outcome measures
| Measure |
Bevacizumab + Chemotherapy
n=14 Participants
Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
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Mean Direct Medical Cost for Cancer Related Medical Care Utilization
Out-Patient Consultation
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0.91 Thousands in New Taiwan Dollar
Standard Deviation 0.407
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Mean Direct Medical Cost for Cancer Related Medical Care Utilization
Hospitalization
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35.9 Thousands in New Taiwan Dollar
Standard Deviation 12.8
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Adverse Events
Bevacizumab + Chemotherapy
Serious adverse events
| Measure |
Bevacizumab + Chemotherapy
n=40 participants at risk
Participants received IV bevacizumab at a dose of 5 mg/kg q2w in combination with standard of care chemotherapy regimen until disease progression or until termination of the study.
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|---|---|
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Blood and lymphatic system disorders
Leukopenia
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2.5%
1/40 • Baseline up to approximately 3 years
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Blood and lymphatic system disorders
Neutropenia
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2.5%
1/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Abdominal pain
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2.5%
1/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Diarrhoea
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5.0%
2/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Gastrointestinal haemorrhage
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7.5%
3/40 • Baseline up to approximately 3 years
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General disorders
Disease progression
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2.5%
1/40 • Baseline up to approximately 3 years
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General disorders
Pyrexia
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2.5%
1/40 • Baseline up to approximately 3 years
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Infections and infestations
Abscess
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2.5%
1/40 • Baseline up to approximately 3 years
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Infections and infestations
Epididymitis
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2.5%
1/40 • Baseline up to approximately 3 years
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Injury, poisoning and procedural complications
Incisional hernia
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2.5%
1/40 • Baseline up to approximately 3 years
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Metabolism and nutrition disorders
Hyponatraemia
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2.5%
1/40 • Baseline up to approximately 3 years
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
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2.5%
1/40 • Baseline up to approximately 3 years
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Renal and urinary disorders
Acute kidney injury
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2.5%
1/40 • Baseline up to approximately 3 years
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Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
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2.5%
1/40 • Baseline up to approximately 3 years
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Vascular disorders
Deep vein thrombosis
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2.5%
1/40 • Baseline up to approximately 3 years
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Other adverse events
| Measure |
Bevacizumab + Chemotherapy
n=40 participants at risk
Participants received IV bevacizumab at a dose of 5 mg/kg q2w in combination with standard of care chemotherapy regimen until disease progression or until termination of the study.
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|---|---|
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Blood and lymphatic system disorders
Leukopenia
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7.5%
3/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Abdominal discomfort
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17.5%
7/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Abdominal distension
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12.5%
5/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Abdominal pain
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7.5%
3/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Constipation
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25.0%
10/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Diarrhoea
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55.0%
22/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Gastrointestinal disorder
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7.5%
3/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Hypoaesthesia oral
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5.0%
2/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Mouth ulceration
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5.0%
2/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Nausea
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67.5%
27/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Periodontal disease
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5.0%
2/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Stomatitis
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32.5%
13/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Toothache
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5.0%
2/40 • Baseline up to approximately 3 years
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Gastrointestinal disorders
Vomiting
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60.0%
24/40 • Baseline up to approximately 3 years
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General disorders
Asthenia
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5.0%
2/40 • Baseline up to approximately 3 years
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General disorders
Chest discomfort
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7.5%
3/40 • Baseline up to approximately 3 years
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General disorders
Chest pain
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5.0%
2/40 • Baseline up to approximately 3 years
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General disorders
Fatigue
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60.0%
24/40 • Baseline up to approximately 3 years
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General disorders
Impaired healing
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5.0%
2/40 • Baseline up to approximately 3 years
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General disorders
Mucosal inflammation
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12.5%
5/40 • Baseline up to approximately 3 years
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General disorders
Oedema peripheral
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5.0%
2/40 • Baseline up to approximately 3 years
|
|
General disorders
Pyrexia
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30.0%
12/40 • Baseline up to approximately 3 years
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Immune system disorders
Hypersensitivity
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7.5%
3/40 • Baseline up to approximately 3 years
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Infections and infestations
Urinary tract infection
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7.5%
3/40 • Baseline up to approximately 3 years
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Investigations
Sensory level abnormal
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27.5%
11/40 • Baseline up to approximately 3 years
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Investigations
Weight decreased
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7.5%
3/40 • Baseline up to approximately 3 years
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Investigations
Weight increased
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5.0%
2/40 • Baseline up to approximately 3 years
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Metabolism and nutrition disorders
Decreased appetite
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37.5%
15/40 • Baseline up to approximately 3 years
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Musculoskeletal and connective tissue disorders
Limb discomfort
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7.5%
3/40 • Baseline up to approximately 3 years
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Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
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5.0%
2/40 • Baseline up to approximately 3 years
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Nervous system disorders
Dizziness
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22.5%
9/40 • Baseline up to approximately 3 years
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Nervous system disorders
Dysgeusia
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10.0%
4/40 • Baseline up to approximately 3 years
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Nervous system disorders
Headache
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20.0%
8/40 • Baseline up to approximately 3 years
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Nervous system disorders
Hypoaesthesia
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27.5%
11/40 • Baseline up to approximately 3 years
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Nervous system disorders
Neuropathy peripheral
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27.5%
11/40 • Baseline up to approximately 3 years
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Psychiatric disorders
Insomnia
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27.5%
11/40 • Baseline up to approximately 3 years
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Respiratory, thoracic and mediastinal disorders
Cough
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20.0%
8/40 • Baseline up to approximately 3 years
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Respiratory, thoracic and mediastinal disorders
Dysphonia
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12.5%
5/40 • Baseline up to approximately 3 years
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
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5.0%
2/40 • Baseline up to approximately 3 years
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Respiratory, thoracic and mediastinal disorders
Epistaxis
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15.0%
6/40 • Baseline up to approximately 3 years
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Respiratory, thoracic and mediastinal disorders
Hiccups
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15.0%
6/40 • Baseline up to approximately 3 years
|
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Respiratory, thoracic and mediastinal disorders
Nasal congestion
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5.0%
2/40 • Baseline up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
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7.5%
3/40 • Baseline up to approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
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5.0%
2/40 • Baseline up to approximately 3 years
|
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Skin and subcutaneous tissue disorders
Alopecia
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37.5%
15/40 • Baseline up to approximately 3 years
|
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Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
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17.5%
7/40 • Baseline up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
5/40 • Baseline up to approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
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12.5%
5/40 • Baseline up to approximately 3 years
|
|
Vascular disorders
Flushing
|
17.5%
7/40 • Baseline up to approximately 3 years
|
|
Vascular disorders
Haemorrhage
|
7.5%
3/40 • Baseline up to approximately 3 years
|
|
Vascular disorders
Hypertension
|
40.0%
16/40 • Baseline up to approximately 3 years
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER