Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-26 @ 6:13 PM
Study NCT ID:
NCT00275951
Status:
COMPLETED
Last Update Posted:
2012-11-16
First Post:
2006-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'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': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-15', 'studyFirstSubmitDate': '2006-01-11', 'studyFirstSubmitQcDate': '2006-01-11', 'lastUpdatePostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed objective response rates', 'timeFrame': 'Confirmed objective response within 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS), overall survival (OS), treatment-related toxicity', 'timeFrame': '3 years and 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Combination', 'Chemotherapy', 'Gastric cancer'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.', 'detailedDescription': 'The clinical efficacy (confirmed objective response rates, progression-free survival, overall survival), and treatment-related toxicities of this novel regimen will be examined as the first-line treatment in patients with nonresectable or recurrent/metastatic gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 75 years\n2. Histologically proven adenocarcinoma\n3. At least one "measurable" lesion (by RECIST)\n4. No prior chemotherapy for gastric cancer\n5. WHO performance status ≦ 2\n6. Adequate baseline organ functions\n7. Fasting serum triglyceride level \\> 70 mg/dL\n8. Written informed consent\n9. At least one month from gastrectomy\n10. Availability of tumor sample for immunohistochemical or pharmacogenomic testing of EGFR\n\nExclusion Criteria:\n\n1. Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy\n2. CNS metastasis\n3. Pregnancy, breast-feeding women and women of child-bearing potential\n4. Life expectancy less 3 months\n5. Serious concomitant illness\n6. Concurrent or prior second malignancy\n7. Known hypersensitivity reaction to any of the components of study treatments'}, 'identificationModule': {'nctId': 'NCT00275951', 'acronym': 'FLAG', 'briefTitle': 'Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Phase II Study of Cetuximab Plus P-HDFL(Cisplatin and Weekly 24-Hour Infusion of High-dose 5-Fluorouracil and Leucovorin)for the First-line Treatment of Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': '941004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cetuximab Plus P-HDFL', 'description': 'Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.', 'interventionNames': ['Drug: Cetuximab Plus P-HDFL']}], 'interventions': [{'name': 'Cetuximab Plus P-HDFL', 'type': 'DRUG', 'description': 'Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.', 'armGroupLabels': ['Cetuximab Plus P-HDFL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Oncology, National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ann-Lii Cheng, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Oncology, National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, {'name': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}, {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}