Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-05 @ 5:55 PM
Study NCT ID:
NCT00261092
Status:
COMPLETED
Last Update Posted:
2008-04-15
First Post:
2005-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GEMOX: 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': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2008-04-14', 'studyFirstSubmitDate': '2005-12-01', 'studyFirstSubmitQcDate': '2005-12-01', 'lastUpdatePostDateStruct': {'date': '2008-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate based on RECIST criteria'}], 'secondaryOutcomes': [{'measure': 'Time to progression'}, {'measure': 'Overall survival'}, {'measure': 'Clinical benefit'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'conditions': ['Pancreatic Neoplasms']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n* To evaluate overall response rate (based on RECIST criterion)\n\nSecondary objective:\n\n* To evaluate time to progression, clinical benefit, quality of life and safety'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically proven adenocarcinoma of the pancreas\n* Metastatic or locally advanced, non resectable disease(Non resectable disease will be determined by the investigators with clinical data)\n* Uni-dimensionally measurable disease as defined by RECIST (primary or secondary tumors\\>2cm using conventional CT scan or ≥1cm with spiral CT scan)\n* No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted\n* Karnofsky Performance Status (KPS) ≥60\n* No known Central Nervous System metastases\n* No sensory neuropathy at inclusion\n* Biological and hematological evaluation \\< 2 weeks prior to treatment administration:\n\n * Neutrophils ≥ 1500/ mm3\n * Platelets ≥ 100,000/mm3\n * Alkaline phosphatases\\< 5X ULN(upper Limits of Normal) and Bilirubin \\< 1.5X ULN\n * SGOT,SGPT \\<2.5 X ULN if no liver metastasis\n * SGOT,SGPT \\<5 X ULN if liver metastasis\n * Creatinine \\< 1.5 X ULN\n* Baseline imaging (CT scan or Magnetic Resonance Imaging) \\<3 weeks before treatment administration\n* Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children\n\nExclusion Criteria:\n\n* Corticotherapy except for anti-emetic purpose\n* Pregnant or breast feeding women (Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs)\n* Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia\n* Uncontrolled or persistent hypercalcemia\n* History of significant neurologic or psychiatric disorders\n* Vater ampulomas and biliary tract adenocarcinomas\n* Other -non cured- malignancies\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00261092', 'briefTitle': 'GEMOX: Oxaliplatin in Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'PM_L_0126'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oxaliplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won-Sik Lee, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'sanofi-avents'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}