Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-24 @ 10:40 PM
Study NCT ID:
NCT02515734
Status:
UNKNOWN
Last Update Posted:
2015-08-05
First Post:
2015-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab
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': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000068818', 'term': 'Cetuximab'}], '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': '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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-04', 'studyFirstSubmitDate': '2015-07-12', 'studyFirstSubmitQcDate': '2015-08-04', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best deepness of response', 'timeFrame': 'up to 2 years', 'description': 'The maximum tumor shrinkage rates by Response Evaluation Criteria in Solid Tumors (RECIST) throughout the treatments'}], 'secondaryOutcomes': [{'measure': 'Early tumor shrinkage', 'timeFrame': 'at 8 weeks', 'description': 'The rates of tumor shrinkage by RECIST at 8 weeks'}, {'measure': 'Response rate', 'timeFrame': 'up to 2 years'}, {'measure': 'Deepness of response', 'timeFrame': 'at 4 months', 'description': 'The tumor shrinkage rates by RECIST at 4 months'}, {'measure': 'Overall survival', 'timeFrame': 'up to 2 years'}, {'measure': 'Progression free survival', 'timeFrame': 'up to 2 years'}, {'measure': 'Rate of curatively resected metastatic lesion', 'timeFrame': 'up to 2 years'}, {'measure': 'Number of adverse events', 'timeFrame': 'up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['FOLFOXIRI', 'Bmab', 'Cmab'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors.', 'detailedDescription': 'This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors. In this study the investigators employed deepness of response as a primary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed colorectal cancer\n* RAS wild-type\n* Measurable lesion by RECIST (Ver.1.1)\n* No past history of chemotherapy in the case of unresectable primary lesion/distant metastasis/lymph node metastasis.In the case of recurrence, no treatment for the first recurrence lesion after operation\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.The case \\>=71 years is PS0.\n* Life expectancy of more than 6 months\n* Patients have enough organ function for study treatment within 14 days before enrollment;\n\n 1. White blood cell (WBC)\\>=3,000/mm3, \\<12,000/mm3.\n 2. Neu\\>=1,500/mm3.\n 3. Platelet count (PLT) \\>=10.0x104/mm3.\n 4. Hb\\>=9.0g/dL.\n 5. Total Bilirubin\\<=1.5x Upper Limited Normal (ULN)\n 6. aspartate aminotransferase (AST) \\<=2.5xULN.\n 7. alanine aminotransferase (ALT) \\<=2.5xULN.\n 8. Creatinine\\<=1.5xULN.\n 9. Proteinuria\\<=1+.\n 10. prothrombin time-international normalized ratio (PT-INR) \\<=1.5\n* Must be able to swallow tablets\n* Written informed consent\n\nExclusion Criteria:\n\n* Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval\n* Lynch syndrome\n* Brain metastases\n* Infectious disease\n* Interstitial lung disease or pulmonary fibrosis\n* Comorbidity or history of serious heart failure\n* History of thromboembolic events\n* Cerebrovascular disease\n* History of hemoptysis/hematemesis\n* Uncontrolled hypertension (systolic BP\\>180mmHg, or diastolic BP\\>100mmHg)\n* Sensory alteration or paresthesia interfering with function\n* Large quantity of pleural, abdominal or cardiac effusion\n* Severe comorbidity (renal failure, liver failure, hypertension, etc)\n* Prior radiotherapy for primary and metastases leision\n* Men/women who are unwilling to avoid pregnancy\n* Women who are pregnant or breastfeeding\n* Women with a positive pregnancy test\n* History of severe allergy\n* HBsAg positive or active viral hepatitis\n* Administration of blood products/ Granulocyte-Colony Stimulating Factor (G-CSF), and blood transfusion within 14 days\n* Surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgery within 28 days\n* Systematic administration of antiplatelet drug or non steroid anti-inflammatory drugs (NSAIDs)\n* Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy\n* History of gastrointestinal perforation within 1 year\n* Unhealed traumatic bone fracture\n* Uncontrolled diarrhea\n* History of organ recipient\n* Prior cetuximab/bevacizumab/Irinotecan/Oxaliplatin treatment (Adjuvant therapy by Oxaliplatin is excluded)\n* Administration of atazanavir sulfate\n* Jaundice\n* Ileus or bowel obstruction\n* Clinical diagnosis of Alzheimer's Disease\n* Insulin dependent diabetes\n* Thyroid disease\n* Any other cases who are regarded as inadequate for study enrollment by investigators"}, 'identificationModule': {'nctId': 'NCT02515734', 'acronym': 'DEEPER', 'briefTitle': 'A Study of FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab', 'organization': {'class': 'OTHER', 'fullName': 'Japan Clinical Cancer Research Organization'}, 'officialTitle': 'A Randomized Phase II Study to Investigate the Deepness of Response of FOLFOXIRI Plus Cetuximab (Erbitux) Versus FOLFOXIRI Plus Bevacizumab as the First-line Therapy in Metastatic Colorectal Cancer Patients With RAS Wild-type Tumors: DEEPER', 'orgStudyIdInfo': {'id': 'JACCRO CC-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FOLFOXIRI+Bmab', 'description': 'Patients in the FOLFOXIRI + Bmab group receive until 12 cycles of FOLFOXIRI plus bevacizumab, consisting of a 30-minute infusion of bevacizumab at a dose of 5 mg per kilogram, a 60-minute infusion of irinotecan at a dose of 150 mg per square meter, and a 120-minute infusion of oxaliplatin at a dose of 85 mg per square meter and a concomitant 120-minute infusion of leucovorin at a dose of 200 mg per square meter, followed by a 48-hour continuous infusion of fluorouracil to a total dose of 2400 mg per square meter. Cycles were repeated every 14 days. After 13 cycles, patients receive fluorouracil, leucovorin and bevacizumab every 14 days until disease progression.', 'interventionNames': ['Drug: fluorouracil', 'Drug: Leucovorin', 'Drug: irinotecan', 'Drug: oxaliplatin', 'Biological: bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'FOLFOXIRI+Cmab', 'description': 'Patients in the experimental group received until 12 cycles of FOLFOXIRI plus cetuximab, consisting of a 30-minute infusion of cetuximab first time at a dose of 400 mg per kilogram, after the second time at a dose of 250mg per kilogram, a 60-minute infusion of irinotecan at a dose of 150 mg per square meter, and a 120-minute infusion of oxaliplatin at a dose of 85 mg per square meter and a concomitant 120-minute infusion of leucovorin at a dose of 200 mg per square meter, followed by a 48-hour continuous infusion of fluorouracil to a total dose of 2400 mg per square meter. Cycles were repeated every 14 days. After 13 cycles, patients receive fluorouracil, leucovorin and cetuximab every 14 days until disease progression.', 'interventionNames': ['Drug: fluorouracil', 'Drug: Leucovorin', 'Drug: irinotecan', 'Drug: oxaliplatin', 'Biological: cetuximab']}], 'interventions': [{'name': 'fluorouracil', 'type': 'DRUG', 'otherNames': ['5-fluorouracil', '5-FU'], 'armGroupLabels': ['FOLFOXIRI+Bmab', 'FOLFOXIRI+Cmab']}, {'name': 'Leucovorin', 'type': 'DRUG', 'otherNames': ['Levofolinate'], 'armGroupLabels': ['FOLFOXIRI+Bmab', 'FOLFOXIRI+Cmab']}, {'name': 'irinotecan', 'type': 'DRUG', 'otherNames': ['CPT-11'], 'armGroupLabels': ['FOLFOXIRI+Bmab', 'FOLFOXIRI+Cmab']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'otherNames': ['eloxatin'], 'armGroupLabels': ['FOLFOXIRI+Bmab', 'FOLFOXIRI+Cmab']}, {'name': 'bevacizumab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['FOLFOXIRI+Bmab']}, {'name': 'cetuximab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['FOLFOXIRI+Cmab']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Masashi Fujii, MD', 'role': 'CONTACT', 'email': 'masashi.fujii@gioncology.jp', 'phone': '+81-3-5579-9882'}, {'name': 'Sachika Koyama, Ms', 'role': 'CONTACT', 'email': 'cc13.dc@jaccro.or.jp', 'phone': '+81-3-5579-9882'}], 'overallOfficials': [{'name': 'Toshifusa Nakajima, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Japan Clinical Cancer Research Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Clinical Cancer Research Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}