Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-30 @ 1:49 AM
Study NCT ID:
NCT00345761
Status:
COMPLETED
Last Update Posted:
2010-08-16
First Post:
2006-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-13', 'studyFirstSubmitDate': '2006-06-27', 'studyFirstSubmitQcDate': '2006-06-27', 'lastUpdatePostDateStruct': {'date': '2010-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': 'event driven'}, {'measure': 'Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)', 'timeFrame': 'throughout study'}], 'secondaryOutcomes': [{'measure': 'time to progression', 'timeFrame': 'event driven'}, {'measure': 'overall survival', 'timeFrame': 'event driven'}, {'measure': 'time to response', 'timeFrame': 'event driven'}, {'measure': 'duration of response', 'timeFrame': 'event driven'}, {'measure': 'concentrations of R340 and its metabolites', 'timeFrame': 'throughout study'}, {'measure': 'concentrations of platinum', 'timeFrame': 'throughout study'}, {'measure': 'concentrations of bevacizumab', 'timeFrame': 'throughout study'}, {'measure': 'concentrations of vascular endothelial growth factor (VEGF)', 'timeFrame': 'throughout study'}, {'measure': 'concentrations of anti-bevacizumab antibody', 'timeFrame': 'throughout study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced and/or metastatic colorectal cancer'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth \\[po\\], day 1 pm-day 15 am every 3 weeks \\[q3w\\]), oxaliplatin (130 mg/m2 intravenously \\[iv\\], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.', 'detailedDescription': 'This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients 20-74 years of age\n* Histologically confirmed colorectal cancer\n* Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease\n* At least one measurable lesion according to RECIST\n\nExclusion Criteria:\n\n* Evidence of clinically detectable ascites at study treatment start\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start.\n* Evidence of bleeding diathesis or coagulopathy\n* Serious, non-healing wound, ulcer, or bone fracture\n* Chronic, daily aspirin (\\> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration'}, 'identificationModule': {'nctId': 'NCT00345761', 'briefTitle': 'Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'JO19380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Step 1', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Step 2', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Step 3', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'description': '7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)', 'armGroupLabels': ['Step 2', 'Step 3']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': '130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)', 'armGroupLabels': ['Step 1', 'Step 2', 'Step 3']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': '2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)', 'armGroupLabels': ['Step 1', 'Step 2', 'Step 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaido', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Region'}, {'city': 'Kanto', 'state': 'Kanto', 'country': 'Japan', 'facility': 'Kanto Region'}, {'city': 'Kinki', 'state': 'Kinki', 'country': 'Japan', 'facility': 'Kinki Region'}, {'city': 'Tōkai', 'state': 'Tokai', 'country': 'Japan', 'facility': 'Tokai Region', 'geoPoint': {'lat': 35.02269, 'lon': 136.90887}}], 'overallOfficials': [{'name': 'Yuji Hayashi', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Development Department 3, Group 6'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Yakult Honsha Co., LTD', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Chugai Pharmaceutical CO.,LTD', 'oldOrganization': 'Chugai Pharmaceutical CO.,LTD'}}}}