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Trial record 91 of 179 for:    colon cancer | ( Map: New Jersey, United States )

A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00642603
Recruitment Status : Terminated
First Posted : March 25, 2008
Results First Posted : June 23, 2011
Last Update Posted : March 29, 2018
Sponsor:
Information provided by:
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: capecitabine [Xeloda]
Drug: bevacizumab [Avastin]
Drug: oxaliplatin
Drug: irinotecan
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title XELOX + Bevacizumab (Q2W) XELIRI + Bevacizumab (Q2W)
Hide Arm/Group Description Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment. Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
Period Title: Overall Study
Started 21 20
Safety Population 19 20
Completed 0 2
Not Completed 21 18
Arm/Group Title XELOX + Bevacizumab (Q2W) XELIRI + Bevacizumab (Q2W) Total
Hide Arm/Group Description Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment. Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment. Total of all reporting groups
Overall Number of Baseline Participants 21 20 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 20 participants 41 participants
63.9  (12.06) 60.6  (9.89) 62.3  (11.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
Female
8
  38.1%
7
  35.0%
15
  36.6%
Male
13
  61.9%
13
  65.0%
26
  63.4%
1.Primary Outcome
Title Progression-free Survival (PFS) in U.S. Patients Only
Hide Description PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.
Time Frame From first patient enrolled up to approximately 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.
Arm/Group Title XELOX + Bevacizumab (Q2W) XELIRI + Bevacizumab (Q2W)
Hide Arm/Group Description:
Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
 
Arm/Group Title XELOX + Bevacizumab (Q2W) XELIRI + Bevacizumab (Q2W)
Hide Arm/Group Description Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment. Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
All-Cause Mortality
XELOX + Bevacizumab (Q2W) XELIRI + Bevacizumab (Q2W)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
XELOX + Bevacizumab (Q2W) XELIRI + Bevacizumab (Q2W)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/19 (21.05%)   7/20 (35.00%) 
Cardiac disorders     
Hypertrophic Cardiomyopathy * 1  1/19 (5.26%)  0/20 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  0/19 (0.00%)  1/20 (5.00%) 
Intestinal Obstruction * 1  0/19 (0.00%)  1/20 (5.00%) 
General disorders     
Asthenia * 1  0/19 (0.00%)  1/20 (5.00%) 
Infections and infestations     
Clostridium Difficile Colitis * 1  1/19 (5.26%)  0/20 (0.00%) 
Pneumonia * 1  0/19 (0.00%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis * 1  1/19 (5.26%)  0/20 (0.00%) 
Nervous system disorders     
Lacunar Infarction * 1  0/19 (0.00%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism * 1  1/19 (5.26%)  2/20 (10.00%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  0/19 (0.00%)  1/20 (5.00%) 
Vascular disorders     
Deep Vein Thrombosis * 1  0/19 (0.00%)  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
XELOX + Bevacizumab (Q2W) XELIRI + Bevacizumab (Q2W)
Affected / at Risk (%) Affected / at Risk (%)
Total   17/19 (89.47%)   19/20 (95.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/19 (5.26%)  3/20 (15.00%) 
Neutropenia * 1  1/19 (5.26%)  1/20 (5.00%) 
Thrombocytopenia * 1  1/19 (5.26%)  1/20 (5.00%) 
Eye disorders     
Vision Blurred * 1  1/19 (5.26%)  0/20 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  9/19 (47.37%)  11/20 (55.00%) 
Nausea * 1  6/19 (31.58%)  11/20 (55.00%) 
Vomiting * 1  4/19 (21.05%)  5/20 (25.00%) 
Abdominal Pain * 1  1/19 (5.26%)  6/20 (30.00%) 
Constipation * 1  3/19 (15.79%)  4/20 (20.00%) 
Abdominal Pain Upper * 1  1/19 (5.26%)  2/20 (10.00%) 
Dyspepsia * 1  2/19 (10.53%)  1/20 (5.00%) 
Stomatitis * 1  0/19 (0.00%)  3/20 (15.00%) 
Flatulence * 1  0/19 (0.00%)  2/20 (10.00%) 
Oral Pain * 1  0/19 (0.00%)  2/20 (10.00%) 
Abdominal Discomfort * 1  0/19 (0.00%)  1/20 (5.00%) 
Anal Pruritus * 1  0/19 (0.00%)  1/20 (5.00%) 
Dry Mouth * 1  1/19 (5.26%)  0/20 (0.00%) 
Gastrointestinal Obstruction * 1  0/19 (0.00%)  1/20 (5.00%) 
Gingival Pain * 1  0/19 (0.00%)  1/20 (5.00%) 
Haematochezia * 1  0/19 (0.00%)  1/20 (5.00%) 
Haemorrhoids * 1  0/19 (0.00%)  1/20 (5.00%) 
Paraesthesia Oral * 1  0/19 (0.00%)  1/20 (5.00%) 
Rectal Haemorrhage * 1  0/19 (0.00%)  1/20 (5.00%) 
Toothache * 1  0/19 (0.00%)  1/20 (5.00%) 
General disorders     
Fatigue * 1  7/19 (36.84%)  7/20 (35.00%) 
Pyrexia * 1  1/19 (5.26%)  3/20 (15.00%) 
Asthenia * 1  0/19 (0.00%)  3/20 (15.00%) 
Malaise * 1  1/19 (5.26%)  2/20 (10.00%) 
Catheter Related Complication * 1  0/19 (0.00%)  1/20 (5.00%) 
Catheter Thrombosis * 1  0/19 (0.00%)  1/20 (5.00%) 
Chest Pain * 1  1/19 (5.26%)  0/20 (0.00%) 
Chills * 1  0/19 (0.00%)  1/20 (5.00%) 
Gait Disturbance * 1  1/19 (5.26%)  0/20 (0.00%) 
Influenza Like Illness * 1  1/19 (5.26%)  0/20 (0.00%) 
Infusion Related Reaction * 1  0/19 (0.00%)  1/20 (5.00%) 
Mucosal Inflammation * 1  0/19 (0.00%)  1/20 (5.00%) 
Oedema * 1  1/19 (5.26%)  0/20 (0.00%) 
Oedema Peripheral * 1  0/19 (0.00%)  1/20 (5.00%) 
Temperature Intolerance * 1  1/19 (5.26%)  0/20 (0.00%) 
Infections and infestations     
Cellulitis * 1  2/19 (10.53%)  0/20 (0.00%) 
Rhinitis * 1  0/19 (0.00%)  2/20 (10.00%) 
Abscess Intestinal * 1  1/19 (5.26%)  0/20 (0.00%) 
Clostridial Infection * 1  0/19 (0.00%)  1/20 (5.00%) 
Clostridium Bacteraemia * 1  1/19 (5.26%)  0/20 (0.00%) 
Escherichia Bacteraemia * 1  1/19 (5.26%)  0/20 (0.00%) 
Gastrointestinal Infection * 1  0/19 (0.00%)  1/20 (5.00%) 
Urinary Tract Infection * 1  0/19 (0.00%)  1/20 (5.00%) 
Viral Infection * 1  0/19 (0.00%)  1/20 (5.00%) 
Vulvovaginal Mycotic Infection * 1  0/19 (0.00%)  1/20 (5.00%) 
Investigations     
Weight Decreased * 1  1/19 (5.26%)  1/20 (5.00%) 
Blood Creatinine Increased * 1  0/19 (0.00%)  1/20 (5.00%) 
Sputum Abnormal * 1  1/19 (5.26%)  0/20 (0.00%) 
X-ray Abnormal * 1  0/19 (0.00%)  1/20 (5.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  3/19 (15.79%)  4/20 (20.00%) 
Anorexia * 1  5/19 (26.32%)  1/20 (5.00%) 
Hypokalaemia * 1  2/19 (10.53%)  3/20 (15.00%) 
Decreased Appetite * 1  2/19 (10.53%)  1/20 (5.00%) 
Hyponatraemia * 1  1/19 (5.26%)  2/20 (10.00%) 
Hypoalbuminaemia * 1  0/19 (0.00%)  2/20 (10.00%) 
Food Intolerance * 1  0/19 (0.00%)  1/20 (5.00%) 
Hyperglycaemia * 1  1/19 (5.26%)  0/20 (0.00%) 
Hypoglycaemia * 1  0/19 (0.00%)  1/20 (5.00%) 
Hypomagnesaemia * 1  1/19 (5.26%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/19 (5.26%)  1/20 (5.00%) 
Musculoskeletal Pain * 1  1/19 (5.26%)  1/20 (5.00%) 
Back Pain * 1  0/19 (0.00%)  1/20 (5.00%) 
Muscle Spasms * 1  0/19 (0.00%)  1/20 (5.00%) 
Musculoskeletal Stiffness * 1  0/19 (0.00%)  1/20 (5.00%) 
Neck Pain * 1  0/19 (0.00%)  1/20 (5.00%) 
Pain In Extremity * 1  0/19 (0.00%)  1/20 (5.00%) 
Nervous system disorders     
Neuropathy Peripheral * 1  9/19 (47.37%)  0/20 (0.00%) 
Dizziness * 1  1/19 (5.26%)  2/20 (10.00%) 
Dysgeusia * 1  1/19 (5.26%)  2/20 (10.00%) 
Headache * 1  1/19 (5.26%)  2/20 (10.00%) 
Peripheral Sensory Neuropathy * 1  1/19 (5.26%)  1/20 (5.00%) 
Burning Sensation * 1  0/19 (0.00%)  1/20 (5.00%) 
Disturbance In Attention * 1  1/19 (5.26%)  0/20 (0.00%) 
Hypoaesthesia * 1  1/19 (5.26%)  0/20 (0.00%) 
Peripheral Motor Neuropathy * 1  1/19 (5.26%)  0/20 (0.00%) 
Restless Legs Syndrome * 1  1/19 (5.26%)  0/20 (0.00%) 
Psychiatric disorders     
Depression * 1  1/19 (5.26%)  1/20 (5.00%) 
Insomnia * 1  2/19 (10.53%)  0/20 (0.00%) 
Anxiety * 1  0/19 (0.00%)  1/20 (5.00%) 
Renal and urinary disorders     
Haematuria * 1  0/19 (0.00%)  1/20 (5.00%) 
Proteinuria * 1  1/19 (5.26%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  0/19 (0.00%)  3/20 (15.00%) 
Cough * 1  0/19 (0.00%)  2/20 (10.00%) 
Dyspnoea * 1  1/19 (5.26%)  1/20 (5.00%) 
Dyspnoea Exertional * 1  1/19 (5.26%)  1/20 (5.00%) 
Hiccups * 1  2/19 (10.53%)  0/20 (0.00%) 
Dysaesthesia Pharynx * 1  1/19 (5.26%)  0/20 (0.00%) 
Nasal Congestion * 1  0/19 (0.00%)  1/20 (5.00%) 
Oropharyngeal Pain * 1  1/19 (5.26%)  0/20 (0.00%) 
Respiratory Tract Congestion * 1  0/19 (0.00%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders     
Palmar-Plantar Erythrodysaesthesia Syndrome * 1  2/19 (10.53%)  2/20 (10.00%) 
Rash * 1  4/19 (21.05%)  0/20 (0.00%) 
Alopecia * 1  0/19 (0.00%)  2/20 (10.00%) 
Pruritus * 1  1/19 (5.26%)  1/20 (5.00%) 
Dry Skin * 1  0/19 (0.00%)  1/20 (5.00%) 
Livedo Reticularis * 1  0/19 (0.00%)  1/20 (5.00%) 
Nail Disorder * 1  0/19 (0.00%)  1/20 (5.00%) 
Night Sweats * 1  0/19 (0.00%)  1/20 (5.00%) 
Urticaria * 1  0/19 (0.00%)  1/20 (5.00%) 
Surgical and medical procedures     
Tooth Extraction * 1  1/19 (5.26%)  0/20 (0.00%) 
Vascular disorders     
Hypertension * 1  0/19 (0.00%)  2/20 (10.00%) 
Flushing * 1  0/19 (0.00%)  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.1)
This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800-821-8590
Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00642603     History of Changes
Other Study ID Numbers: ML21567
First Submitted: March 19, 2008
First Posted: March 25, 2008
Results First Submitted: June 10, 2010
Results First Posted: June 23, 2011
Last Update Posted: March 29, 2018