Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-02 @ 6:23 PM
Study NCT ID:
NCT00598156
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2008-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva
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': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-19', 'studyFirstSubmitDate': '2008-01-09', 'studyFirstSubmitQcDate': '2008-01-17', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '23922111', 'type': 'DERIVED', 'citation': 'Hansen TF, Christensen Rd, Andersen RF, Sorensen FB, Johnsson A, Jakobsen A. MicroRNA-126 and epidermal growth factor-like domain 7-an angiogenic couple of importance in metastatic colorectal cancer. Results from the Nordic ACT trial. Br J Cancer. 2013 Sep 3;109(5):1243-51. doi: 10.1038/bjc.2013.448. Epub 2013 Aug 6.'}, {'pmid': '23788755', 'type': 'DERIVED', 'citation': 'Johnsson A, Hagman H, Frodin JE, Berglund A, Keldsen N, Fernebro E, Sundberg J, De Pont Christensen R, Garm Spindler KL, Bergstrom D, Jakobsen A. A randomized phase III trial on maintenance treatment with bevacizumab alone or in combination with erlotinib after chemotherapy and bevacizumab in metastatic colorectal cancer: the Nordic ACT Trial. Ann Oncol. 2013 Sep;24(9):2335-41. doi: 10.1093/annonc/mdt236. Epub 2013 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab and erlotinib (Tarceva).', 'detailedDescription': 'Patients with metastatic colorectal cancer will be treated with standard chemotherapy according to the investigators choice. In addition to chemotherapy, Avastin (bevacizumab) will be given during the treatment period. After the chemotherapy is finished (after 18 weeks), maintenance therapy will be given and the patients will be randomized to treatment with either with Avastin alone or Avastin in combination with Tarceva (erlotinib). Patients with progressive disease, or patients suitable to curative resection of metastases will be taken out of study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adenocarcinoma of the colon or rectum.\n2. Age \\> 18.\n3. Measurable disease according to RECIST criteria.\n4. Expected survival more than three months.\n5. Adequate bone marrow, liver and kidney function.\n6. INR \\< 1.5 times upper limit.\n7. Adequate contraception for fertile patients.\n8. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Earlier chemotherapy for metastatic colorectal cancer.\n2. Adjuvant treatment within 6 months.\n3. Surgery or significant trauma within 28 days prior to study entry.\n4. Planned radiotherapy against target lesions.\n5. CNS metastases.\n6. Prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma.\n7. Bleeding diathesis\n8. Uncontrolled hypertension.\n9. Significant cardiovascular disease.\n10. Treatment with anticoagulant drugs.\n11. Participation in other clinical trial.\n12. Pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT00598156', 'acronym': 'ACT', 'briefTitle': 'Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva', 'organization': {'class': 'OTHER', 'fullName': 'Lund University Hospital'}, 'officialTitle': 'Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.', 'orgStudyIdInfo': {'id': 'ML19033'}, 'secondaryIdInfos': [{'id': 'EUDRACT 2006-002295-18'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression', 'interventionNames': ['Drug: erlotinib (Tarceva)', 'Drug: bevacizumab (Avastin)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression', 'interventionNames': ['Drug: bevacizumab (Avastin)']}], 'interventions': [{'name': 'erlotinib (Tarceva)', 'type': 'DRUG', 'description': 'Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)', 'armGroupLabels': ['1']}, {'name': 'bevacizumab (Avastin)', 'type': 'DRUG', 'description': 'Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Vejle Hospital, Department of Oncology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Esbjerg Hospital', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'city': 'Herning', 'country': 'Denmark', 'facility': 'Herning Hospital', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Hillerod Hospital, Department of Oncology', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense Hospital, Department of Oncology', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Roskilde Hospital, Department of Oncology', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}, {'city': 'Jönköping', 'country': 'Sweden', 'facility': 'Ryhov Hospital, Department of Oncology', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'city': 'Kalmar', 'country': 'Sweden', 'facility': 'Kalmar Hospital, Department of Oncology', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}, {'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University Hospital, Department of Oncology', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'University Hospital MAS', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital, Department of Oncology', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Sundsvall', 'country': 'Sweden', 'facility': 'Sundsvall Hospital, Department of Oncology', 'geoPoint': {'lat': 62.39129, 'lon': 17.3063}}, {'city': 'Umeå', 'country': 'Sweden', 'facility': 'University Hospital of Norrland, Department of Oncology', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Akademiska Hospital, Department of Oncology', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Vaxjo', 'country': 'Sweden', 'facility': 'Vaxjo Hospital, Department of Oncology', 'geoPoint': {'lat': 56.87767, 'lon': 14.80906}}], 'overallOfficials': [{'name': 'Anders Johnsson, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University Hospital, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}