Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT00227734
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-04', 'studyFirstSubmitDate': '2005-09-26', 'studyFirstSubmitQcDate': '2005-09-26', 'lastUpdatePostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment'}], 'secondaryOutcomes': [{'measure': 'Clinical benefit (CR, PR, and stable disease [SD]) measured at 18 weeks after randomization'}, {'measure': 'Time to progression'}, {'measure': 'Overall survival'}, {'measure': 'Time to treatment failure measured after completion of study treatment'}, {'measure': 'Adverse drug reactions measured after completion of study treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'stage IV rectal cancer', 'recurrent colon cancer', 'recurrent rectal cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '18349029', 'type': 'RESULT', 'citation': 'Borner M, Koeberle D, Von Moos R, Saletti P, Rauch D, Hess V, Trojan A, Helbling D, Pestalozzi B, Caspar C, Ruhstaller T, Roth A, Kappeler A, Dietrich D, Lanz D, Mingrone W; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland. Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK. Ann Oncol. 2008 Jul;19(7):1288-1292. doi: 10.1093/annonc/mdn058. Epub 2008 Mar 17.'}]}, '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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine and oxaliplatin together with cetuximab is more effective than capecitabine and oxaliplatin in treating colorectal cancer.\n\nPURPOSE: This randomized phase II trial is studying how well giving capecitabine and oxaliplatin together with cetuximab works compared to capecitabine and oxaliplatin in treating patients with metastatic colorectal cancer that cannot be removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of capecitabine and oxaliplatin with vs without cetuximab in patients with epidermal growth factor receptor-positive metastatic unresectable colorectal cancer.\n* Compare the objective response (complete and partial response) in patients treated with these regimens.\n\nSecondary\n\n* Compare the safety of these regimens in these patients.\n* Compare the clinical benefit (complete response, partial response, or stable disease for at least 18 weeks) in patients treated with these regimens.\n* Compare overall survival, time to progression, and time to treatment failure in patients treated with these regimens.\n\nOUTLINE: This is a multicenter, randomized study. Patients are stratified according to performance status (0 vs 1), type of metastases (synchronous vs metachronous), prior adjuvant chemotherapy (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.\n* Arm II: Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8.\n\nIn both arms, courses repeat every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients will be followed every 3 months for 1 year and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 74 patients (37 per treatment arm) will be accrued for this study within 1.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed metastatic colorectal cancer\n\n * Unresectable disease\n * Primary tumor or metastases must be epidermal growth factor receptor-positive by immunohistochemistry\n* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by CT scan\n\n * Measurable lesion must not be in a previously irradiated area\n* No prior or current CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* WHO 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin normal\n\nRenal\n\n* Creatinine clearance \\> 50 ml/min\n\nCardiovascular\n\n* No New York Heart Association class III or IV congestive heart failure\n* No symptomatic coronary artery disease\n* No uncontrolled cardiac arrhythmia\n* No myocardial infarction within the past 12 months\n* No other significant cardiac disease\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for 12 months after study participation\n* Negative pregnancy test\n* No peripheral neuropathy of any origin \\> grade 1 (e.g., alcohol or diabetes)\n* No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or absorption of oral medication\n* No severe reaction attributed to fluoropyrimidine therapy\n* No known hypersensitivity to fluorouracil or any other component of the trial drugs\n* No known dihydropyrimidine dehydrogenase deficiency\n* No other medical condition (e.g., uncontrolled diabetes or active autoimmune disease), geographical situation, or psychiatric disorder that would preclude study compliance\n* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy for advanced or metastatic cancer\n* At least 6 months since prior adjuvant chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 30 days since prior experimental drugs\n* No other concurrent experimental drugs\n* No concurrent drugs that are contraindicated for use with the trial drugs\n* No other concurrent anticancer therapy\n* No concurrent sorivudine or any of its chemically-related analogues (e.g., lamivudine)'}, 'identificationModule': {'nctId': 'NCT00227734', 'briefTitle': 'Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Cancer Institute'}, 'officialTitle': 'Capecitabine and Oxaliplatin Alone or in Combination With Cetuximab as First-Line Treatment for Metastatic EGFR-Positive Colorectal Cancer, A Randomized Multicenter Phase II Trial', 'orgStudyIdInfo': {'id': 'SAKK 41/04'}, 'secondaryIdInfos': [{'id': 'EU-20525'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I', 'description': 'Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.', 'interventionNames': ['Drug: capecitabine and oxaliplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II', 'description': 'Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8', 'interventionNames': ['Drug: capecitabine and oxaliplatin + cetuximab']}], 'interventions': [{'name': 'capecitabine and oxaliplatin + cetuximab', 'type': 'DRUG', 'description': 'cetuximab', 'armGroupLabels': ['Arm II']}, {'name': 'capecitabine and oxaliplatin', 'type': 'DRUG', 'description': 'capecitabine and oxaliplatin without cetuximab', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5001', 'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Kantonspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': 'CH-5001', 'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Hirslanden Klinik Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '5404', 'city': 'Baden', 'country': 'Switzerland', 'facility': 'Praxis Dr. Streit', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}, {'zip': 'CH-5404', 'city': 'Baden', 'country': 'Switzerland', 'facility': 'Kantonsspital Baden', 'geoPoint': {'lat': 47.47333, 'lon': 8.30592}}, {'zip': 'CH-4016', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Saint Claraspital AG', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': 'CH-4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitaetsspital-Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': 'CH-3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': 'CH-4101', 'city': 'Bruderholz', 'country': 'Switzerland', 'facility': 'Kantonsspital Bruderholz', 'geoPoint': {'lat': 47.5296, 'lon': 7.59902}}, {'zip': 'CH-7000', 'city': 'Chur', 'country': 'Switzerland', 'facility': 'Spitaeler Chur AG', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'zip': 'CH-1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hopital Cantonal Universitaire de Geneve', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': 'CH-4410', 'city': 'Liestal', 'country': 'Switzerland', 'facility': 'Kantonsspital', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}, {'zip': 'CH-6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Ospedale Civico', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'zip': '4310', 'city': 'Rheinfelden', 'country': 'Switzerland', 'facility': 'Praxis Dr. Beretta', 'geoPoint': {'lat': 47.55437, 'lon': 7.79403}}, {'zip': 'CH-9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital - St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '3600', 'city': 'Thun', 'country': 'Switzerland', 'facility': 'Regionalspital', 'geoPoint': {'lat': 46.75118, 'lon': 7.62166}}, {'zip': '8063', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'City Hospital Triemli', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'CH-8037', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Stadtspital Waid', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'CH-8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitaetsSpital Zuerich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Markus M. Borner, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Insel Gruppe AG, University Hospital Bern'}, {'name': 'Dieter Koeberle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Hospital of St. Gallen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}