Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-03 @ 6:14 AM
Study NCT ID:
NCT00940303
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2009-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic 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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2009-07-06', 'studyFirstSubmitQcDate': '2009-07-15', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'assessed every 8 weeks up to week 102, 3-monthly during follow-up'}], 'secondaryOutcomes': [{'measure': 'Overall survival; proportion of patients achieving R0 resectability; objective response rate (complete response [CR] and partial response [PR]); proportion of patients completing 12 cycles of chemotherapy.', 'timeFrame': 'assessed every 4 weeks up to week 102 and at the end of follow-up period'}, {'measure': 'Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.', 'timeFrame': 'Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks'}]}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '26335608', 'type': 'DERIVED', 'citation': 'Stein A, Atanackovic D, Hildebrandt B, Stubs P, Brugger W, Hapke G, Steffens CC, Illerhaus G, Bluemner E, Stohlmacher J, Bokemeyer C. Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer. Br J Cancer. 2015 Sep 15;113(6):872-7. doi: 10.1038/bjc.2015.299. Epub 2015 Sep 3.'}]}, 'descriptionModule': {'briefSummary': 'This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is \\<100 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-70 years of age;\n* metastatic colorectal cancer scheduled for standard first line chemotherapy;\n* at least 1 measurable lesion;\n* ECOG performance score of 0 or 1.\n\nExclusion Criteria:\n\n* prior chemotherapy for metastatic colorectal cancer;\n* prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy completed within 6 months prior to study entry;\n* concomitant malignancies other CRC;\n* history or evidence of CNS disease unrelated to cancer.'}, 'identificationModule': {'nctId': 'NCT00940303', 'briefTitle': 'OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)', 'orgStudyIdInfo': {'id': 'ML20514'}, 'secondaryIdInfos': [{'id': '2008-001180-11'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: 5-FU', 'Drug: bevacizumab [Avastin]', 'Drug: irinotecan', 'Drug: leucovorin', 'Drug: oxaliplatin']}], 'interventions': [{'name': '5-FU', 'type': 'DRUG', 'description': '3200mg/m2 continuous iv infusions, day 1 every 2 weeks', 'armGroupLabels': ['1']}, {'name': 'bevacizumab [Avastin]', 'type': 'DRUG', 'description': '5mg/kg iv infusion, day 1 every 2 weeks', 'armGroupLabels': ['1']}, {'name': 'irinotecan', 'type': 'DRUG', 'description': '165mg/m2 iv infusion, day 1 every 2 weeks', 'armGroupLabels': ['1']}, {'name': 'leucovorin', 'type': 'DRUG', 'description': '200mg/m2 iv infusion, day 1 every 2 weeks', 'armGroupLabels': ['1']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'description': '85mg/m2 iv infusion, day 1 every 2 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13347', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '29221', 'city': 'Celle', 'country': 'Germany', 'geoPoint': {'lat': 52.62264, 'lon': 10.08047}}, {'zip': '29223', 'city': 'Celle', 'country': 'Germany', 'geoPoint': {'lat': 52.62264, 'lon': 10.08047}}, {'zip': '06847', 'city': 'Dessau', 'country': 'Germany', 'geoPoint': {'lat': 51.83864, 'lon': 12.24555}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '36043', 'city': 'Fulda', 'country': 'Germany', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22087', 'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30171', 'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '26789', 'city': 'Leer', 'country': 'Germany', 'geoPoint': {'lat': 53.23157, 'lon': 7.461}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '39130', 'city': 'Magdeburg', 'country': 'Germany', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '90419', 'city': 'Nuremberg', 'country': 'Germany', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '21680', 'city': 'Stade', 'country': 'Germany', 'geoPoint': {'lat': 53.59407, 'lon': 9.47302}}, {'zip': '78052', 'city': 'Villingen-Schwenningen', 'country': 'Germany', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}