Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT00416494
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2006-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brant.hamel@duke.edu', 'phone': '919-68-1861', 'title': 'Brant Hamel', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Initial Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1', 'otherNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Second Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort', 'otherNumAtRisk': 31, 'otherNumAffected': 29, 'seriousNumAtRisk': 31, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal Cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'General disorders'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Flatuance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hand-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders'}, {'term': 'Skin rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Bowel Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Acute Calculus Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Wound Dehisence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Altered mental status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate (Percentage of Participants With Partial or Complete Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1'}, {'id': 'OG001', 'title': 'Second Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '38', 'upperLimit': '84'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.', 'description': 'Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.\n\nDisease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.\n\nThe definitions were:\n\nComplete 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', 'unitOfMeasure': 'percentage of participants with response', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who had restaging scans were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1'}, {'id': 'OG001', 'title': 'Second Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '5.7', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '19.5'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '15.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of treatment until documented progression, assesed up to 60 months.', 'description': 'Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.\n\nProgressive 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.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1'}, {'id': 'OG001', 'title': 'Second Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '19.5'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '15.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.', 'description': 'Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.\n\nProgressive 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.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1'}, {'id': 'OG001', 'title': 'Second Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000', 'lowerLimit': '13.3', 'upperLimit': '30.2'}, {'value': '24.8', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '39.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From time of treatment until death from any cause, assesed up to 60 months.', 'description': 'Average months of survival of participants after receiving study drug.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1'}, {'id': 'OG001', 'title': 'Second Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After all participants went off study drug regimine.', 'description': 'Number of participants with adverse events', 'unitOfMeasure': 'participants with adverse event', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Effect on Angiogenesis Biomarkers', 'timeFrame': 'After study completion', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Effect on Wound Angiogenesis', 'timeFrame': 'After study completion', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Initial Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1'}, {'id': 'FG001', 'title': 'Second Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited between September 2003 and July 2005 in the Duke Cancer Center and Duke Oncology Network sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Initial Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1'}, {'id': 'BG001', 'title': 'Second Cohort', 'description': 'oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.\n\nbevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1\n\nCapecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '55.3', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '55', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-25', 'studyFirstSubmitDate': '2006-12-27', 'resultsFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2006-12-27', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-12', 'studyFirstPostDateStruct': {'date': '2006-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect on Angiogenesis Biomarkers', 'timeFrame': 'After study completion'}, {'measure': 'Effect on Wound Angiogenesis', 'timeFrame': 'After study completion'}], 'primaryOutcomes': [{'measure': 'Response Rate (Percentage of Participants With Partial or Complete Response)', 'timeFrame': 'After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.', 'description': 'Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.\n\nDisease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.\n\nThe definitions were:\n\nComplete 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'}], 'secondaryOutcomes': [{'measure': 'Time to Progression', 'timeFrame': 'From time of treatment until documented progression, assesed up to 60 months.', 'description': 'Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.\n\nProgressive 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.'}, {'measure': 'Disease Free Survival', 'timeFrame': 'From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.', 'description': 'Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.\n\nProgressive 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.'}, {'measure': 'Overall Survival', 'timeFrame': 'From time of treatment until death from any cause, assesed up to 60 months.', 'description': 'Average months of survival of participants after receiving study drug.'}, {'measure': 'Safety and Tolerability', 'timeFrame': 'After all participants went off study drug regimine.', 'description': 'Number of participants with adverse events'}]}, 'conditionsModule': {'keywords': ['adenocarcinoma of the colon', 'recurrent colon cancer', 'stage IV colon cancer', 'adenocarcinoma of the rectum', 'recurrent rectal cancer', 'stage IV rectal cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Hurwitz H, Fernando N, Yu D, et al.: A phase II study of oxaliplatin, capecitabine and bevacizumab in the treatment of metastatic colorectal cancer. [Abstract] Ann Oncol 16 (Suppl 2): A-55P, ii285, 2005.'}, {'pmid': '23634291', 'type': 'DERIVED', 'citation': 'Liu Y, Starr MD, Bulusu A, Pang H, Wong NS, Honeycutt W, Amara A, Hurwitz HI, Nixon AB. Correlation of angiogenic biomarker signatures with clinical outcomes in metastatic colorectal cancer patients receiving capecitabine, oxaliplatin, and bevacizumab. Cancer Med. 2013 Apr;2(2):234-42. doi: 10.1002/cam4.71. Epub 2013 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Evaluate the response rate in patients with previously untreated metastatic colorectal cancer treated with capecitabine, oxaliplatin, and bevacizumab.\n\nSecondary\n\n* Assess time to progression (TTP), disease-free survival (DFS), and overall survival (OS) in patients treated with this regimen.\n* Assess the safety and tolerability of bevacizumab, oxaliplatin, and capecitabine in patients with previously untreated metastatic colorectal cancer.\n\nExploratory\n\n* Evaluate the effect of this regimen on the biomarkers of angiogenesis.\n* Assess the effect of this regimen on wound angiogenesis.\n\nOUTLINE: Patients receive oral capecitabine twice daily on days 1-5 and 8-12, oxaliplatin IV over 2 hours on day 1, and bevacizumab IV over 1-1½ hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically documented adenocarcinoma of the colon or rectum\n\n * Metastatic or recurrent disease not amenable to potentially curative treatment (e.g., inoperable metastatic disease)\n* No leptomeningeal or brain metastases\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Absolute neutrophil count ≥ 2,000/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* AST/ALT \\< 2.5 times upper limit of normal (ULN) (5 times ULN if known liver metastases)\n* Bilirubin \\< 1.5 times ULN\n* Creatinine clearance \\> 50 mL/min\n* No unstable or poorly controlled hypertension (\\> 150/100 mm Hg)\n\n * Patients who have recently started or adjusted antihypertensive medications are eligible provided blood pressure is \\< 140/90 mm Hg on any new regimen for at least 3 different observations over 14 days\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during study and for at least 3-4 months after study completion\n* No arterial or venous thrombosis (including cerebrovascular accident) within the last 3 months\n* No known, existing, uncontrolled coagulopathy\n* No clinically significant cardiac disease\n* No congestive heart failure\n* No symptomatic coronary artery disease\n* No cardiac arrhythmias not well controlled with medication\n* No myocardial infarction within the last 12 months\n* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, capecitabine, or bevacizumab\n* No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 4 weeks since prior sorivudine or brivudine\n* At least 6 months since prior adjuvant treatment with fluorouracil and leucovorin calcium or a fluorouracil and leucovorin calcium-based regimen\n* No major surgery within 4 weeks without complete recovery\n* No prior chemotherapy for metastatic/recurrent disease\n* No cancer immunotherapy or other biologic therapy while on therapy\n* No radiotherapy while on study\n* No hormonal therapy for cancer while on study\n* No full-dose warfarin (INR of \\> 1.5), heparin (\\> 10,000 units/day), or thrombolytic agents\n* Allopurinol and cimetidine should be discontinued prior to starting on this regimen'}, 'identificationModule': {'nctId': 'NCT00416494', 'briefTitle': 'Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Pro00008646'}, 'secondaryIdInfos': [{'id': 'DUMC-4951-05-7R2'}, {'id': 'GENENTECH-DUMC-4951-05-7R2'}, {'id': 'SANOFI-DUMC-4951-05-7R2'}, {'id': 'ROCHE-DUMC-4951-05-7R2'}, {'id': 'CDR0000449971', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Initial Cohort', 'interventionNames': ['Biological: bevacizumab', 'Drug: oxaliplatin', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Second cohort', 'interventionNames': ['Biological: bevacizumab', 'Drug: oxaliplatin', 'Drug: Capecitabine']}], 'interventions': [{'name': 'bevacizumab', 'type': 'BIOLOGICAL', 'description': '10 mg/kg intravenously over 30-90 minutes on day 1', 'armGroupLabels': ['Initial Cohort', 'Second cohort']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'description': '85 mg/m2 intravenously over 2 hours on day 1.', 'armGroupLabels': ['Initial Cohort', 'Second cohort']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort', 'armGroupLabels': ['Initial Cohort']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort', 'armGroupLabels': ['Second cohort']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Herbert I. Hurwitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herbert Hurwitz, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Herbert Hurwitz, MD', 'investigatorAffiliation': 'Duke University'}}}}