Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-29 @ 9:23 AM
Study NCT ID:
NCT00564720
Status:
TERMINATED
Last Update Posted:
2013-02-15
First Post:
2007-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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': 140}}, 'statusModule': {'whyStopped': 'Due to poor accrual of the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-14', 'studyFirstSubmitDate': '2007-11-27', 'studyFirstSubmitQcDate': '2007-11-27', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '1 year survival'}], 'secondaryOutcomes': [{'measure': 'Progression free interval', 'timeFrame': '1 year'}, {'measure': 'Response rate', 'timeFrame': 'Objective responses confirmed by CT or MRI on 3rd and 6th cycle'}, {'measure': 'Toxicity profile', 'timeFrame': 'Toxicity assessment on each chemotherapy cycle'}, {'measure': 'Symptoms improvement', 'timeFrame': 'Assessment every two cycles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed pancreatic cancer.\n* Measurable disease.\n* Absence of ascites or obstructive jaundice.\n* ECOG Performance Status 0-2.\n* Adequate liver kidney and bone marrow function.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Chronic diarrheic syndrome.\n* Uncontrolled brain metastases after radiation.\n* Liver infiltration over 50%.\n* Peripheral neuropathy ≥ 2.\n* No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix.\n* No active uncontrolled infection.\n* Active cardiac disease : unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure \\> class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\n* Women who are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT00564720', 'briefTitle': 'Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Oncology Research Group'}, 'officialTitle': 'Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CT/06.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'GEM/TAR', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Erlotinib']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'GEM/OX/TAR', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Erlotinib', 'Drug: Oxaliplatin']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': 'Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles', 'armGroupLabels': ['1']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': 'Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles', 'armGroupLabels': ['2']}, {'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': 'Erlotinib 100 mg by mouth (p.o.), daily until disease progression', 'armGroupLabels': ['1', '2']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin'], 'description': 'Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University General Hospital of Alexandroupolis, Department of Medical Oncology', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Air Forces Military Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Errikos Ntynan General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'IASO General Hospital of Athens, 1st Department of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': "Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology", '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': 'Thessaloniki', 'country': 'Greece', 'facility': 'Diabalkaniko General Hospital of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Vassilis Georgoulias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Crete, Dep of Medical Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Oncology Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Crete', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}