Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-29 @ 1:10 PM
Study NCT ID:
NCT00447967
Status:
COMPLETED
Last Update Posted:
2009-09-28
First Post:
2007-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients
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': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-25', 'studyFirstSubmitDate': '2007-03-14', 'studyFirstSubmitQcDate': '2007-03-14', 'lastUpdatePostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rates', 'timeFrame': 'Objective responses confirmed by CT or MRI (on 3rd and 6th cy)'}], 'secondaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': '1 year'}, {'measure': 'Toxicity', 'timeFrame': 'Toxicity assessment on each chemotherapy cycle'}, {'measure': 'Overall survival', 'timeFrame': '1 year'}, {'measure': 'Quality of life', 'timeFrame': 'Assessment every two cycles'}, {'measure': 'Symptoms improvement', 'timeFrame': 'Assessment every two cycles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metastatic Gastric Cancer', 'Oxaliplatin', 'Irinotecan'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This phase II trial will compare the efficacy and toxicity of the combination of Irinotecan and Oxaliplatin versus 5-FU/LV and Oxaliplatin as first line treatment in patients with locally advanced or metastatic gastric cancer', 'detailedDescription': 'There is no regimen considered standard in advanced gastric cancer. The reported response rates of 5-FU-based combination chemotherapy are higher than single agents (10-50%) but more toxic. The combination of 5-FU/LV and LOHP has demonstrated an ORR of 43%, median TTP of approximately 6,5 months and OS of 8,6 months in phase II trials, with an acceptable toxicity.\n\nIrinotecan (CPT-11) is effective as salvage treatment in metastatic gastric cancer and has a synergistic activity with LOHP in preclinical trials'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed locally advanced or metastatic gastric cancer.\n* Measurable or evaluable disease.\n* Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.\n* Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.\n* Karnofsky performance status \\> 70%.\n* Age ≥18 years.\n* Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function.\n* Patients must be able to understand the nature of this study and give written informed consent.\n\nExclusion Criteria:\n\n* Active infection\n* History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)\n* Previous radiotherapy within the last 4 weeks or \\> 25% of bone marrow.\n* Patients with CNS metastases\n* Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction.\n* Malnutrition or loss of \\> 10% of body weight during the last month.\n* Peripheral neuropathy ≥ grade 2\n* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.\n* Psychiatric illness or social situation that would preclude study compliance.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT00447967', 'briefTitle': 'Combination of CPT-11 and LoHP vs Combination of 5-FU, Leucovorin and LoHP as 1st Line Treatment in Gastric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Oncology Research Group'}, 'officialTitle': 'A Randomized Phase II Study of Irinotecan and Oxaliplatin Versus the Combination of 5-FU/LV and Oxaliplatin, as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer', 'orgStudyIdInfo': {'id': 'CT/04.18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'IOX', 'interventionNames': ['Drug: Irinotecan', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'FLOX', 'interventionNames': ['Drug: Fluorouracil', 'Drug: Leucovorin', 'Drug: Oxaliplatin']}], 'interventions': [{'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['CPT-11'], 'description': 'Irinotecan 200 mg/m2 IV on Day 1 every 3 weeks for 6 cycles', 'armGroupLabels': ['1']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['LoHP'], 'description': 'Oxaliplatin 80 mg/m2 IV on Day 2 every 3 weeks for 6 cycles', 'armGroupLabels': ['1']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'otherNames': ['5-FU'], 'description': 'Fluorouracil 400 mg/m2 infused over 10 min IV and Fluorouracil600 mg/m2 infused over 22 hours IV, Day 1 and 2 (De Grammont regimen)every 2 weeks for 12 cycles', 'armGroupLabels': ['2']}, {'name': 'Leucovorin', 'type': 'DRUG', 'otherNames': ['LV'], 'description': 'Leucovorin 200 mg/m2 infused over 1 hour IV on day 1 and day 2 (De Grammont regimen) every 2 weeks for 12 cycles', 'armGroupLabels': ['2']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['LoHP'], 'description': 'Oxaliplatin 85 mg/m2 as a 4 hour IV infusion, Day 1 every 4 weeks for 6 cycles', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71110', 'city': 'Heraklion', 'state': 'Crete', 'country': 'Greece', 'facility': 'University Hospital of Crete', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University General Hospital of Alexandroupolis, Dep of Medical Oncology', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"IASO" General Hospital of Athens, 1st Dep of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '401 Military Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Air Forces Military Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Larissa', 'country': 'Greece', 'facility': 'State General Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'city': 'Piraeus', 'country': 'Greece', 'facility': '"Metaxa\'s" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}], 'overallOfficials': [{'name': 'Ioannis Boukovinas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Oncology Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Crete', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'I.Boukovinas', 'oldOrganization': 'Hellenic Oncology Research Group'}}}}