Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00107315
Recruitment Status : Terminated (Terminated due to low accrual)
First Posted : April 6, 2005
Results First Posted : July 4, 2014
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: bevacizumab
Drug: capecitabine
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combination of Capecitabine and Bevacizumab
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 16
Completed 1
Not Completed 15
Reason Not Completed
Disease Progression             9
Adverse Event             4
Withdrawal by Subject             2
Arm/Group Title Combination of Capecitabine and Bevacizumab
Hide Arm/Group Description 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 Number of Baseline Participants 16
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
78  (4.9)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
16
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
11
  68.8%
Male
5
  31.3%
1.Primary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Combination of Capecitabine and Bevacizumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Response Rate
Hide Description Overall Response (OR) = CR + PR.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Combination of Capecitabine and Bevacizumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Median Survival
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Combination of Capecitabine and Bevacizumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Toxicity
Hide Description

Number of participants with an adverse event.

Please refer to the adverse event reporting for more detail.

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the study’s early termination and inadequate number of patients, no patients were analyzed.
Arm/Group Title Combination of Capecitabine and Bevacizumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combination of Capecitabine and Bevacizumab
Hide Arm/Group Description 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.
All-Cause Mortality
Combination of Capecitabine and Bevacizumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Combination of Capecitabine and Bevacizumab
Affected / at Risk (%) # Events
Total   11/16 (68.75%)    
Cardiac disorders   
Atrial thrombosis   1/16 (6.25%)  2
Gastrointestinal disorders   
Diarrhoea   1/16 (6.25%)  2
Enteritis   1/16 (6.25%)  1
Intestinal ischaemia   1/16 (6.25%)  2
Large intestine perforation   1/16 (6.25%)  2
Nausea   1/16 (6.25%)  2
Proctalgia   1/16 (6.25%)  2
Vomiting   1/16 (6.25%)  2
General disorders   
Pain   1/16 (6.25%)  2
Nervous system disorders   
Syncope   1/16 (6.25%)  2
Transient ischaemic attack   2/16 (12.50%)  4
Renal and urinary disorders   
Haematuria   1/16 (6.25%)  2
Reproductive system and breast disorders   
Pelvic pain   1/16 (6.25%)  2
Vascular disorders   
Arterial thrombosis   1/16 (6.25%)  2
Deep vein thrombosis   1/16 (6.25%)  2
Venous thrombosis   1/16 (6.25%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Combination of Capecitabine and Bevacizumab
Affected / at Risk (%) # Events
Total   16/16 (100.00%)    
Blood and lymphatic system disorders   
Anaemia   4/16 (25.00%)  8
Cardiac disorders   
Bradycardia   1/16 (6.25%)  1
Ear and labyrinth disorders   
Tinnitus   1/16 (6.25%)  2
Vertigo   1/16 (6.25%)  2
Eye disorders   
Dry eye   1/16 (6.25%)  2
Keratoconjunctivitis sicca   1/16 (6.25%)  2
Lacrimation increased   1/16 (6.25%)  2
Gastrointestinal disorders   
Anal discomfort   1/16 (6.25%)  2
Ascites   1/16 (6.25%)  2
Diarrhoea   4/16 (25.00%)  17
Dry mouth   1/16 (6.25%)  4
Flatulence   1/16 (6.25%)  8
Nausea   2/16 (12.50%)  3
Stomatitis   3/16 (18.75%)  8
Toothache   1/16 (6.25%)  2
Vomiting   2/16 (12.50%)  4
General disorders   
Chest pain   1/16 (6.25%)  2
Fatigue   4/16 (25.00%)  9
Injection site reaction   2/16 (12.50%)  4
Mucosal inflammation   1/16 (6.25%)  1
Oedema   1/16 (6.25%)  6
Oedema peripheral   1/16 (6.25%)  2
Pyrexia   1/16 (6.25%)  2
Immune system disorders   
Hypersensitivity   1/16 (6.25%)  2
Infections and infestations   
Cystitis   1/16 (6.25%)  2
Enteritis infectious   1/16 (6.25%)  2
Nail infection   2/16 (12.50%)  4
Nasopharyngitis   1/16 (6.25%)  2
Pneumonia   1/16 (6.25%)  2
Rhinitis   1/16 (6.25%)  4
Sinusitis   1/16 (6.25%)  2
Subcutaneous abscess   1/16 (6.25%)  2
Upper respiratory tract infection   1/16 (6.25%)  2
Urinary tract infection   2/16 (12.50%)  6
Injury, poisoning and procedural complications   
Rib fracture   1/16 (6.25%)  2
Tooth injury   1/16 (6.25%)  2
Wound   1/16 (6.25%)  2
Investigations   
Alanine aminotransferase increased   1/16 (6.25%)  4
Aspartate aminotransferase increased   1/16 (6.25%)  4
Blood alkaline phosphatase increased   1/16 (6.25%)  2
Blood creatinine   1/16 (6.25%)  2
Haemoglobin   1/16 (6.25%)  4
Haemoglobin decreased   1/16 (6.25%)  2
Protein total increased   1/16 (6.25%)  2
Protein urine   1/16 (6.25%)  2
Weight increased   1/16 (6.25%)  2
Metabolism and nutrition disorders   
Anorexia   2/16 (12.50%)  5
Dehydration   2/16 (12.50%)  3
Hyperglycaemia   8/16 (50.00%)  35
Hyperkalaemia   2/16 (12.50%)  4
Hypernatraemia   1/16 (6.25%)  2
Hypoalbuminaemia   3/16 (18.75%)  6
Hypocalcaemia   2/16 (12.50%)  4
Hypoglycaemia   2/16 (12.50%)  3
Hypokalaemia   2/16 (12.50%)  3
Musculoskeletal and connective tissue disorders   
Arthralgia   2/16 (12.50%)  4
Nervous system disorders   
Convulsion   1/16 (6.25%)  2
Coordination abnormal   2/16 (12.50%)  4
Dizziness   2/16 (12.50%)  4
Dysgeusia   1/16 (6.25%)  4
Paraesthesia   1/16 (6.25%)  4
Psychiatric disorders   
Depression   1/16 (6.25%)  2
Renal and urinary disorders   
Cystitis-like symptom   1/16 (6.25%)  2
Dysuria   1/16 (6.25%)  2
Leukocyturia   1/16 (6.25%)  2
Stress urinary incontinence   1/16 (6.25%)  2
Urinary incontinence   1/16 (6.25%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnoea   2/16 (12.50%)  4
Epistaxis   1/16 (6.25%)  8
Skin and subcutaneous tissue disorders   
Alopecia   1/16 (6.25%)  2
Blood blister   1/16 (6.25%)  2
Hyperhidrosis   1/16 (6.25%)  2
Palmar-plantar erythrodysaesthesia syndrome   14/16 (87.50%)  50
Rash   2/16 (12.50%)  4
Skin hyperpigmentation   1/16 (6.25%)  2
Skin ulcer   1/16 (6.25%)  2
Vascular disorders   
Hypertension   4/16 (25.00%)  10
Indicates events were collected by systematic assessment
Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00107315     History of Changes
Other Study ID Numbers: I 22204
RPCI-I-22204
GENENTECH-RPCI-I-22204
First Submitted: April 5, 2005
First Posted: April 6, 2005
Results First Submitted: January 8, 2014
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014