Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT01338558
Status:
WITHDRAWN
Last Update Posted:
2016-11-02
First Post:
2011-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab
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': 'D000068818', 'term': 'Cetuximab'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-04-18', 'studyFirstSubmitQcDate': '2011-04-18', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria', 'timeFrame': 'up to 4 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'up to 4 years'}, {'measure': 'Objective response rate', 'timeFrame': '4 years'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': '4 years'}, {'measure': 'Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30)', 'timeFrame': 'up to 4 years'}, {'measure': 'Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms', 'timeFrame': 'up to 4 years'}]}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients \\>/= 18 years of age\n* Histologically confirmed adenocarcinoma of the colon or rectum\n* Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria\n* Tumour tissue sample available for assessment of K-RAS and BRAF genes\n* Prior radiotherapy must have been completed 4 weeks before randomization\n* Adequate bone marrow, kidney and liver function\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n\nExclusion Criteria:\n\n* Previous chemotherapy for metastatic disease\n* Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization\n* Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors\n* Clinical or radiographic evidence of brain metastases\n* Clinically significant cardiovascular disease or disorder\n* History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours\n* HIV, hepatitis B or C infection'}, 'identificationModule': {'nctId': 'NCT01338558', 'briefTitle': 'A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'orgStudyIdInfo': {'id': 'ML25686'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'K-RAS mutated', 'interventionNames': ['Drug: bevacizumab [Avastin]', 'Drug: mFOLFOX6']}, {'type': 'EXPERIMENTAL', 'label': 'K-RAS native A', 'interventionNames': ['Drug: bevacizumab [Avastin]', 'Drug: mFOLFOX6']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'K-RAS native B', 'interventionNames': ['Drug: cetuximab', 'Drug: mFOLFOX6']}], 'interventions': [{'name': 'bevacizumab [Avastin]', 'type': 'DRUG', 'description': '5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent', 'armGroupLabels': ['K-RAS mutated', 'K-RAS native A']}, {'name': 'cetuximab', 'type': 'DRUG', 'description': '400 mg /m2 iv on Day 1, followed by 250 mg/m2 every week until disease progression, unacceptable toxicity or withdrawal of consent', 'armGroupLabels': ['K-RAS native B']}, {'name': 'mFOLFOX6', 'type': 'DRUG', 'description': 'Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent', 'armGroupLabels': ['K-RAS mutated', 'K-RAS native A', 'K-RAS native B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}