Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-29 @ 4:41 AM
Study NCT ID:
NCT00514020
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2007-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D054458', 'term': 'Amplified Fragment Length Polymorphism Analysis'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016172', 'term': 'DNA Fingerprinting'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura.goff@vanderbilt.edu', 'phone': '615-936-0059', 'title': 'Laura Goff, MD', 'organization': 'Vanderbilt-Ingram Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oxaliplatin + Leucovorin + 5-Fluorouracil', 'description': 'Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.', 'otherNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'albumin, serum-low', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 29, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Investigations'}, {'term': 'ALT/SGPT (serum glutamine pyruvic transminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Investigations'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'ascites (non-malignant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'AST, SGOT (serum glutamine oxaloacetic transminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Investigations'}, {'term': 'bilirubin (hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'calcium, serum-low-hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'creatine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'dermatology/skin-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'distension/bloating, abdominal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'edema-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'General disorders'}, {'term': 'glucose, serum-high-hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 21, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'heartburn/dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 33, 'numAffected': 22}], 'organSystem': 'Investigations'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders'}, {'term': 'leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 32, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 19, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'metabolic/laboratory-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'mood alteration-anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'mood alteration-depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'mucositis/stomatitis (clinical exam)-oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Mucositis/stomatitis (functional/symptomatic)-oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 22, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'neuropathy - sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 39, 'numAffected': 14}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 40, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'pain-abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pain-extremity-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'pain-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 32, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'potassium, serum-low (hypokalemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'rash-hand-foot skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'sodium, serum-low (hyponatremia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Taste alteration (dysgeusia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'vision/blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'fever in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 12e9/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'infection with normal ANC or Grade 1 or 2 neutrophils-abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}], 'seriousEvents': [{'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'distension/bloating, abdominal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'fever (in the absence of neutropenia, where neutropenia is defined as ANC < 1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'obstruction, GU-ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'pain-abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'INR (international normalized ratio of prothrombin)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'death not associated with CTCAE-disease progression NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'infection with normal ANC or Grade 1 or 2 neutrophils-skin (cellulitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'supraventricular and nodal arrhythmia-atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'AST, SGOT (serum glutamic oxaloacetic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin + Leucovorin + 5-Fluorouracil', 'description': 'Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'every 8 weeks to progression', 'description': 'Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \\> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \\> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients available for measurement of response. All patients who received Oxaliplatin + Leucovorin + 5-Fluorouracil are in the heterozygous "good risk" genotype group. One patient was not evaluable for response.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5-FU, Leucovorin, Oxaliplatin', 'description': 'Patients who have TSER\\*2/\\*2 or TSER\\*2/\\*3 genotypes will receive the modified FOLFOX-6 treatment. Patients homozygous for TSER\\*3 will not be included in study.\n\n* FOLFOX-6 chemotherapy: oxaliplatin IV in 500 ml D5W over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15.\n* Treatment courses repeat every 2 weeks +/- 3 days (2 treatments per cycle) in the absence of unacceptable toxicity or disease progression. Disease assessments will be performed after 8 weeks (2 cycles) of treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'two patients withdrew before treatment; one withdrew after treatment', 'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'other complicating disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'patient went to radiation treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'patients moved to the "no tx" group', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'This study was conducted from August 2007 to March 2011.', 'preAssignmentDetails': 'Forty-two patients signed consent, 9 of which were found to be ineligible to participate in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxaliplatin + Leucovorin + 5-Fluorouracil', 'description': 'Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-30', 'studyFirstSubmitDate': '2007-08-08', 'resultsFirstSubmitDate': '2012-09-18', 'studyFirstSubmitQcDate': '2007-08-08', 'lastUpdatePostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-18', 'studyFirstPostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])', 'timeFrame': 'every 8 weeks to progression', 'description': 'Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \\> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \\> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the stomach', 'stage IV gastric cancer', 'recurrent gastric cancer'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.vicc.org/ct/', 'label': 'Vanderbilt-Ingram Cancer Center, Find a Clinical Trial'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the response rate in patients with "good risk" genotype (TSER\\*2/\\*2 or TSER\\*2/\\*3 genotype \\[low TS expression\\]) to historical control response rates in non-genotype selected patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.\n\nAvailable tumor tissue samples are assessed for expression of TS at the mRNA and protein levels. The results are correlated with germline and tumor TSER genotypes as well as response to the study treatment regimen. Polymorphisms in other genes associated with treatment outcome or toxicity are also assessed.\n\nAfter completion of study treatment, patients are followed periodically for 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\n\n * Metastatic disease\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan\n* No known active brain metastases\n\n * Patients with treated brain metastases are eligible if stable off steroids for at least 30 days\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)\n* Life expectancy ≥ 3 months\n* WBC ≥ 3,000/μL\n* Absolute neutrophil count ≥ 1,500/μL\n* Platelets ≥ 100,000/μL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* AST or ALT ≤ 2.5 x ULN (\\< 5 x ULN if known liver metastases)\n* Creatinine clearance ≤ 1.5 x ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 21 days after completion of study treatment\n* No history of allergic reactions to fluorouracil or oxaliplatin\n* No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior therapy for metastatic disease\n\n * Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval has been longer than 6 months\n* No other concurrent chemotherapy\n* No concurrent combination anti-retroviral therapy for HIV-positive patients\n* No concurrent routine prophylaxis with filgrastim (G-CSF)\n* No other concurrent antineoplastic agents, including chemotherapy, radiation therapy, or biologic agents'}, 'identificationModule': {'nctId': 'NCT00514020', 'briefTitle': 'Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study', 'orgStudyIdInfo': {'id': 'VICC GI 0716'}, 'secondaryIdInfos': [{'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VICC-GI-0716'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Drug: fluorouracil', 'Drug: leucovorin calcium', 'Drug: oxaliplatin', 'Genetic: gene expression analysis', 'Genetic: polymorphism analysis', 'Genetic: protein expression analysis', 'Other: pharmacological study']}], 'interventions': [{'name': 'fluorouracil', 'type': 'DRUG', 'description': 'Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.', 'armGroupLabels': ['Treatment']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'description': 'through a vein over 2 hours on days 1 and 15.', 'armGroupLabels': ['Treatment']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'description': '500 ml D5W through a vein over 2 hours on days 1 and 15.', 'armGroupLabels': ['Treatment']}, {'name': 'gene expression analysis', 'type': 'GENETIC', 'description': 'Blood collection', 'armGroupLabels': ['Treatment']}, {'name': 'polymorphism analysis', 'type': 'GENETIC', 'description': 'Blood collection', 'armGroupLabels': ['Treatment']}, {'name': 'protein expression analysis', 'type': 'GENETIC', 'description': 'Blood collection', 'armGroupLabels': ['Treatment']}, {'name': 'pharmacological study', 'type': 'OTHER', 'description': 'Blood collection', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '37064', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center - Cool Springs', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37064', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center at Franklin', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Laura W. Goff, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist', 'investigatorFullName': 'Laura W. Goff, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}