Trial Outcomes & Findings for Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer (NCT NCT00107315)
NCT ID: NCT00107315
Last Updated: 2014-07-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
1 year
Results posted on
2014-07-04
Participant Flow
Participant milestones
| Measure |
Combination of Capecitabine and Bevacizumab
Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Combination of Capecitabine and Bevacizumab
Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
|
|---|---|
|
Overall Study
Disease Progression
|
9
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Combination of Capecitabine and Bevacizumab
n=16 Participants
Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
|
|---|---|
|
Age, Continuous
|
78 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Overall Response (OR) = CR + PR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.
Outcome measures
Outcome data not reported
Adverse Events
Combination of Capecitabine and Bevacizumab
Serious events: 11 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination of Capecitabine and Bevacizumab
n=16 participants at risk
Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
|
|---|---|
|
Cardiac disorders
Atrial thrombosis
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Enteritis
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Large intestine perforation
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Proctalgia
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 2
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 2
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 2
|
|
Nervous system disorders
Transient ischaemic attack
|
12.5%
2/16 • Number of events 4
|
|
Renal and urinary disorders
Haematuria
|
6.2%
1/16 • Number of events 2
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.2%
1/16 • Number of events 2
|
|
Vascular disorders
Arterial thrombosis
|
6.2%
1/16 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis
|
6.2%
1/16 • Number of events 2
|
|
Vascular disorders
Venous thrombosis
|
6.2%
1/16 • Number of events 2
|
Other adverse events
| Measure |
Combination of Capecitabine and Bevacizumab
n=16 participants at risk
Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
4/16 • Number of events 8
|
|
Cardiac disorders
Bradycardia
|
6.2%
1/16 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
6.2%
1/16 • Number of events 2
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16 • Number of events 2
|
|
Eye disorders
Dry eye
|
6.2%
1/16 • Number of events 2
|
|
Eye disorders
Keratoconjunctivitis sicca
|
6.2%
1/16 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Anal discomfort
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Ascites
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
4/16 • Number of events 17
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 3
|
|
Gastrointestinal disorders
Stomatitis
|
18.8%
3/16 • Number of events 8
|
|
Gastrointestinal disorders
Toothache
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 4
|
|
General disorders
Chest pain
|
6.2%
1/16 • Number of events 2
|
|
General disorders
Fatigue
|
25.0%
4/16 • Number of events 9
|
|
General disorders
Injection site reaction
|
12.5%
2/16 • Number of events 4
|
|
General disorders
Mucosal inflammation
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Oedema
|
6.2%
1/16 • Number of events 6
|
|
General disorders
Oedema peripheral
|
6.2%
1/16 • Number of events 2
|
|
General disorders
Pyrexia
|
6.2%
1/16 • Number of events 2
|
|
Immune system disorders
Hypersensitivity
|
6.2%
1/16 • Number of events 2
|
|
Infections and infestations
Cystitis
|
6.2%
1/16 • Number of events 2
|
|
Infections and infestations
Enteritis infectious
|
6.2%
1/16 • Number of events 2
|
|
Infections and infestations
Nail infection
|
12.5%
2/16 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 2
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Number of events 2
|
|
Infections and infestations
Subcutaneous abscess
|
6.2%
1/16 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
12.5%
2/16 • Number of events 6
|
|
Injury, poisoning and procedural complications
Rib fracture
|
6.2%
1/16 • Number of events 2
|
|
Injury, poisoning and procedural complications
Tooth injury
|
6.2%
1/16 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound
|
6.2%
1/16 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • Number of events 4
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
1/16 • Number of events 2
|
|
Investigations
Blood creatinine
|
6.2%
1/16 • Number of events 2
|
|
Investigations
Haemoglobin
|
6.2%
1/16 • Number of events 4
|
|
Investigations
Haemoglobin decreased
|
6.2%
1/16 • Number of events 2
|
|
Investigations
Protein total increased
|
6.2%
1/16 • Number of events 2
|
|
Investigations
Protein urine
|
6.2%
1/16 • Number of events 2
|
|
Investigations
Weight increased
|
6.2%
1/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
2/16 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
2/16 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
50.0%
8/16 • Number of events 35
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
2/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.2%
1/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
18.8%
3/16 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
2/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
12.5%
2/16 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
2/16 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
2/16 • Number of events 4
|
|
Nervous system disorders
Convulsion
|
6.2%
1/16 • Number of events 2
|
|
Nervous system disorders
Coordination abnormal
|
12.5%
2/16 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • Number of events 4
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16 • Number of events 4
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 2
|
|
Renal and urinary disorders
Cystitis-like symptom
|
6.2%
1/16 • Number of events 2
|
|
Renal and urinary disorders
Dysuria
|
6.2%
1/16 • Number of events 2
|
|
Renal and urinary disorders
Leukocyturia
|
6.2%
1/16 • Number of events 2
|
|
Renal and urinary disorders
Stress urinary incontinence
|
6.2%
1/16 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
1/16 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
2/16 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
87.5%
14/16 • Number of events 50
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.2%
1/16 • Number of events 2
|
|
Vascular disorders
Hypertension
|
25.0%
4/16 • Number of events 10
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place