Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-31 @ 11:10 PM
Study NCT ID:
NCT01087658
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2010-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity
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': 'D005973', 'term': 'Glutamine'}, {'id': 'D002118', 'term': 'Calcium'}, {'id': 'D008274', 'term': 'Magnesium'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D019565', 'term': 'Metals, Light'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-20', 'studyFirstSubmitDate': '2010-03-15', 'studyFirstSubmitQcDate': '2010-03-15', 'lastUpdatePostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of peripheral sensory neuropathy (PSN) grade 2, 3 and 4 assessed by the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE)', 'timeFrame': 'Every cycle i.e. 2 or 3 weeks according to the treatment arm'}], 'secondaryOutcomes': [{'measure': 'Cumulative dose of oxaliplatin and time of onset when the first PSN grade 2, 3 or 4 occurs', 'timeFrame': 'Every cycle i.e. 2 or 3 weeks according to the treatment arm'}, {'measure': 'Dose-reduction, dose-delay and discontinuation of oxaliplatin due to PSN grade 3 or 4', 'timeFrame': 'Every cycle i.e. 2 or 3 weeks according to the treatment arm'}, {'measure': 'Patient self-reported neurotoxicity scale for chronic peripheral neuropathy', 'timeFrame': 'Every cycle i.e. 2 or 3 weeks according to the treatment arm'}, {'measure': 'Progression Free Survival / PFS (for metastatic patients)', 'timeFrame': 'Every cycle i.e. 2 or 3 weeks according to the treatment arm'}]}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo assess the benefit of glutamine when added to calcium-magnesium on the occurrence of grade 2, 3 and 4 peripheral sensory neuropathy (PSN) related to oxaliplatin with the National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) scale taking into account the time from start of oxaliplatin at which the first event occurred.\n\nSecondary Objective:\n\nTo determine cumulative dose of oxaliplatin and time when the first occurrence of grade 2, 3 or 4 PSN.\n\nTo determine the incidence of dose-reductions, dose-delays and discontinuations of oxaliplatin due to PSN grade 3 or 4.\n\nTo assess effects of glutamine when added to calcium-magnesium on patients-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12 items questionnaire (FACT/GOG NTX-12) subscale.\n\nTo evaluate the incidence of diarrhea. To determine Progression Free Survival (PFS) in metastatic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Histologically- or cytologically- proven adenocarcinoma of the colon or rectum.\n2. Disease either in adjuvant or 1st line metastatic setting.\n3. Eastern Cooperation Oncology Group (ECOG) performance status inferior or equal to 2.\n4. At least 4 weeks following any major surgical procedure(s) and recovery from any surgical sequelae.\n5. Electrocardiogram (ECG) with no acute or recent changes within limit of normal range, and not presenting abnormalities contraindicating the proposed chemotherapy.\n6. Adequate liver and kidney function:\n\n * Total bilirubin inferior to 1.5 ULN\n * Serum creatinine inferior to 150 umol/L\n * Creatinine clearance (ClCr) superior to 45 mL/min\n * ALT/AST inferior to 3 ULN\n * Alkaline phosphatase inferior or equal to 2 ULN, unless liver metastases are present and documented at baseline by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans (inferior or equal to 3,5 ULN in that case).\n7. Adequate hematological function:\n\n * Neutrophils superior or equal to 1.5 x 109/L\n * Platelet count superior or equal to 100 x 109/L\n * Hemoglobin superior to 9 g/dL\n\nExclusion criteria:\n\n1. Any condition or past medical history that contra-indicates treatment with oxaliplatin, 5-fluorouracil (5-FU), leucovorin (LV) or capecitabine as reported in the approved labeling information.\n2. Previous oxaliplatin-based chemotherapy.\n3. Previous or current diagnosis of PSN.\n4. Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing PSN: carbamazepine, amitriptyline, gabapentin, phenytoin, glutathione, alpha-lipoic acid, celecoxib, amifostine, venlafaxine, vitamin B1 (thiamine), B6 (pyridoxine).\n5. History of known allergy to oxaliplatin or other platinum agents, 5-FU, LV or capecitabine.\n6. History of known allergy to glutamine or to calcium-magnesium.\n7. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.\n8. Uncontrolled intercurrent illness: e.g. high blood pressure, unstable angina, symptomatic congestive heart failure (New York Heart Association Classification III or IV),\n9. Serious cardiac arrhythmia, diabetes, or active infection.\n10. Concurrent active cancer originating from a primary site other than colon or rectum.\n11. Presence of any symptom suggesting brain metastasis.\n12. Patients who are pregnant or breast-feeding\n13. Patients (males and females) with reproductive potential not implementing accepted and effective method of contraception\n14. For patient who will receive Bevacizumab: Bevacizumab is contraindicated in patients with known hypersensitivity to any components of the product to Chinese hamster ovary cell product or other recombinant human or humanized antibodies\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01087658', 'acronym': 'GLUTOX', 'briefTitle': 'Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multicentre, Randomized, Open-label, Phase III Study Comparing the Efficacy of Oral Glutamine and Calcium-magnesium With Calcium-magnesium Alone in the Prevention of Oxaliplatin-induced Neurotoxicity in Patients With Colorectal Cancer Treated With Oxaliplatin in Adjuvant or 1st Line Metastatic Settings.', 'orgStudyIdInfo': {'id': 'OXALI_L_03768'}, 'secondaryIdInfos': [{'id': 'U1111-1116-9494', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glutamine and calcium magnesium', 'description': 'Glutamine 10g p.o. 3-times a day beginning at day -2 for 7 consecutive days during each chemotherapy cycle. 1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion.\n\nAll patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6.', 'interventionNames': ['Drug: Glutamine', 'Drug: Calcium and Magnesium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium magnesium', 'description': '1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion.\n\nAll patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6.', 'interventionNames': ['Drug: Calcium and Magnesium']}], 'interventions': [{'name': 'Glutamine', 'type': 'DRUG', 'description': 'Per os', 'armGroupLabels': ['Glutamine and calcium magnesium']}, {'name': 'Calcium and Magnesium', 'type': 'DRUG', 'description': 'Intravenous', 'armGroupLabels': ['Calcium magnesium', 'Glutamine and calcium magnesium']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J4V2H1', 'city': 'Greenfield Park', 'country': 'Canada', 'facility': 'Investigational Site Number 0001', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H7M3L9', 'city': 'Laval', 'country': 'Canada', 'facility': 'Investigational Site Number 124-005', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': 'N6A 4L6', 'city': 'London', 'country': 'Canada', 'facility': 'Investigational Site Number 124-007', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Moncton', 'country': 'Canada', 'facility': 'Investigational Site Number 124-014', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 124-006', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 124-004', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W1S6', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 124010', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2X 1P1', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 124-011', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'country': 'Canada', 'facility': 'Investigational Site Number 124-015', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'K1H8L6', 'city': 'Ottawa', 'country': 'Canada', 'facility': 'Investigational Site Number 124-012', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'country': 'Canada', 'facility': 'Investigational Site Number 124-003', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G5L5T1', 'city': 'Rimouski', 'country': 'Canada', 'facility': 'Investigational Site Number 124-017', 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}, {'zip': 'M5G2M9', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Investigational Site Number 124-002', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'R2H2A6', 'city': 'Winnipeg', 'country': 'Canada', 'facility': 'Investigational Site Number 124-016', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}