Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-02-01 @ 4:45 PM
Study NCT ID:
NCT01532804
Status:
TERMINATED
Last Update Posted:
2019-12-26
First Post:
2012-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2nd-line Treatment of 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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], '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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'whyStopped': 'too slow recruiting', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-24', 'studyFirstSubmitDate': '2012-02-10', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '6 months', 'description': 'DFS is estimated from the date of randomization until the first date of objectively documented event or death'}], 'secondaryOutcomes': [{'measure': 'Treatment-related toxicity', 'timeFrame': '6 months', 'description': 'Treatment-related toxicity is evaluated according to the NCI-CTCAE v.4 criteria.'}, {'measure': 'Objective response rate', 'timeFrame': 'Every 9 weeks', 'description': 'Objective response rate is evaluated according to the RECIST V 1.1 criteria.'}, {'measure': 'Overall survival', 'timeFrame': 'unk', 'description': 'OS is estimated from the date of randomization until the date of death from any cause'}, {'measure': 'Cost-effectiveness study', 'timeFrame': '6 months', 'description': 'The cost-effectiveness study includes the number of hospital stays (treatment and toxicity), the global cost of treatments, and the cost of hospital stays due to treatment-induced toxicity'}, {'measure': 'Quality of life by using the quality of life questionnaire score', 'timeFrame': '6 months', 'description': 'Quality of life is measured using the QLQ-C30 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Unresectable metastases'], 'conditions': ['Metastatic Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.', 'detailedDescription': 'Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors:\n\n* Center\n* Number of metastatic sites: 1 versus \\> 1\n* Bevacizumab-based first-line therapy: Yes versus No'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven colorectal cancer\n* Resected or asymptomatic primary tumor\n* Metastatic colorectal cancer not eligible for curative surgery\n* No major surgery within four weeks of the start of study treatment\n* At least one target lesion unidimensionally measurable on cross-sectional imaging according to RECIST criteria (v1.1)\n* Disease progression after failure of irinotecan-based chemotherapy\n* Bone metastases are allowed if there is at least one other measurable metastatic site\n* CT scan of the abdomen, chest and pelvis within 3 weeks of the start of study treatment\n* WHO PS ≤ 2\n* Platelet count \\>= 100,000 mm3\n* Hemoglobin \\> 10g/dl\n* Bilirubin \\< 1.5 ULN, AST/ALT \\< 5 ULN\n* Serum creatinine \\< 1.5 ULN, creatinine clearance \\> 60 ml/min (Cockcroft)\n* A time period of 4 weeks should be respected between the end of previous treatments and study enrollment\n* Negative pregnancy test in women of childbearing potential\n* Male or female using an effective contraceptive method\n* Absence of known or symptomatic brain metastases\n* Life expectancy \\> 3 months\n* Informed consent signed prior any study specific procedures\n\nExclusion Criteria:\n\n* Prior raltitrexed-based chemotherapy\n* Prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months)\n* Uncontrolled arterial hypertension defined as systolic pressure \\> 150 mm Hg or diastolic pressure \\> 100 mm Hg\n* Malignant hypertension or hypertensive encephalopathy\n* Myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry\n* Hemorrhagic diathesis or significant pathology of coagulation\n* Peripheral neuropathy grade\\>2 (NCI-CTC v4.0)\n* Hemoptysis \\< 1 month\n* Venous access device (PAC) or any other minor surgery such as a biopsy within the last 7 days\n* Symptomatic brain metastases or carcinomatous meningitis\n* History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer and in situ cervical cancer)\n* Severe bacterial or fungal infection (Grade \\> 2 NCI-CTCAE v.4.0)\n* Known or suspected sensitivity to one of the study drugs\n* Pregnant or breastfeeding women\n* Previous enrollment in an investigational drug study within the last 4 weeks\n* Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up)'}, 'identificationModule': {'nctId': 'NCT01532804', 'acronym': 'BEVATOMOX', 'briefTitle': '2nd-line Treatment of Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'BEVATOMOX'}, 'secondaryIdInfos': [{'id': '2010-023447-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'FOLFOX6 + bevacizumab (D1=D15, 12 cycles)', 'interventionNames': ['Drug: bevacizumab, oxaliplatin and 5FU combination']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Raltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles)', 'interventionNames': ['Drug: Bevacizumab, oxaliplatin and raltitrexed combination']}], 'interventions': [{'name': 'bevacizumab, oxaliplatin and 5FU combination', 'type': 'DRUG', 'description': 'Bevacizumab 5 mg/kg administered as an iv infusion for 1h30, then for 1h and for 30 min. at the following cycles, respectively.\n\nOxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles)', 'armGroupLabels': ['Arm A']}, {'name': 'Bevacizumab, oxaliplatin and raltitrexed combination', 'type': 'DRUG', 'description': 'Bevacizumab 7.5 mg/kg administered as an iv infusion for 1h30, then administered for 1h and 30 min at the following cycles, respectively.\n\nOxaliplatin 130 mg/m² administered as an iv infusion for 2h Raltitrexed 3 mg/m² administered as an iv infusion for 15 min', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Val d'Aurelle Cancer Institute", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Emmanuelle Samalin-Scalzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Val d'Aurelle Cancer Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}