Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-30 @ 5:20 AM
Study NCT ID:
NCT00448760
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2007-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D005467', 'term': 'Floxuridine'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D020133', 'term': 'Reverse Transcriptase Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003857', 'term': 'Deoxyuridine'}, {'id': 'D014529', 'term': 'Uridine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bardalan@med.miami.edu', 'phone': '305-243-4909', 'title': 'Bach Ardalan MD, Professor', 'organization': 'UM/Sylvester Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Single Arm', 'description': 'Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles\n\nLeucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles\n\nConventional surgery : Surgical removal of tumor for correlative studies\n\nreverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy\n\nDocetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles\n\nMicroarray analysis : Analysis of tumor for pathologic response to protocol therapy\n\nOxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 25}], 'seriousEvents': [{'term': 'Grade 3 Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Grade 4 Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Grade 3 Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Grade 3Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Grade 3 Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 9}], 'organSystem': 'General disorders'}, {'term': 'Grade 3 Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Grade 3 Deep Venous Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Grade 3 Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathologic Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles\n\nLeucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles\n\nConventional surgery : Surgical removal of tumor for correlative studies\n\nreverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy\n\nDocetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles\n\nMicroarray analysis : Analysis of tumor for pathologic response to protocol therapy\n\nOxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '34.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 - 16 weeks', 'description': 'No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles\n\nLeucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles\n\nConventional surgery : Surgical removal of tumor for correlative studies\n\nreverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy\n\nDocetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles\n\nMicroarray analysis : Analysis of tumor for pathologic response to protocol therapy\n\nOxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000', 'lowerLimit': '55.7', 'upperLimit': '85.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 - 16 weeks', 'description': 'Overall response = Complete response (CR) + Partial Response (PR). Evaluated via endoscopic ultrasounds, PET and CT scans of the chest:\n\nComplete Response (CR) applies to participants complete disappearance of all measurable and evaluable disease. No new lesion. No disease related symptoms. No evidence of non-evaluable disease, including tumor markers and other laboratory values.\n\nPartial Response (PR) applies to participants with at least 50 percent reduction in the sum of the products of bi-dimensional perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles\n\nLeucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles\n\nConventional surgery : Surgical removal of tumor for correlative studies\n\nreverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy\n\nDocetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles\n\nMicroarray analysis : Analysis of tumor for pathologic response to protocol therapy\n\nOxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 months', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles\n\nLeucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles\n\nConventional surgery : Surgical removal of tumor for correlative studies\n\nreverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy\n\nDocetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles\n\nMicroarray analysis : Analysis of tumor for pathologic response to protocol therapy\n\nOxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '32.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 months', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neoadjuvant + Adjuvant Chemotherapy', 'description': 'Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles\n\nLeucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles\n\nConventional surgery : Surgical removal of tumor for correlative studies\n\nreverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy\n\nDocetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles\n\nMicroarray analysis : Analysis of tumor for pathologic response to protocol therapy\n\nOxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm', 'description': '5-Fluorodeoxyuridine, Leucovorin, Oxaliplatin and Docetaxel'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-14', 'studyFirstSubmitDate': '2007-03-15', 'resultsFirstSubmitDate': '2013-01-16', 'studyFirstSubmitQcDate': '2007-03-15', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-16', 'studyFirstPostDateStruct': {'date': '2007-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic Complete Response', 'timeFrame': '8 - 16 weeks', 'description': 'No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.'}], 'secondaryOutcomes': [{'measure': 'Clinical Response', 'timeFrame': '8 - 16 weeks', 'description': 'Overall response = Complete response (CR) + Partial Response (PR). Evaluated via endoscopic ultrasounds, PET and CT scans of the chest:\n\nComplete Response (CR) applies to participants complete disappearance of all measurable and evaluable disease. No new lesion. No disease related symptoms. No evidence of non-evaluable disease, including tumor markers and other laboratory values.\n\nPartial Response (PR) applies to participants with at least 50 percent reduction in the sum of the products of bi-dimensional perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.'}, {'measure': 'Median Progression-free Survival (PFS)', 'timeFrame': '24 months'}, {'measure': 'Overall Survival', 'timeFrame': '24 months'}]}, 'conditionsModule': {'keywords': ['stage II esophageal cancer', 'stage III esophageal cancer', 'adenocarcinoma of the esophagus'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '21258083', 'type': 'RESULT', 'citation': 'Solomon N, Mezentsev D, Reis I, Lima M, Rios J, Avisar E, Franceschi D, Livingstone A, Podolsky L, Ardalan B. A phase II study of neoadjuvant and adjuvant chemotherapy with 5-fluorodeoxyuridine, leucovorin, oxaliplatin and docetaxel in the treatment of previously untreated advanced esophageal adenocarcinoma. Jpn J Clin Oncol. 2011 Apr;41(4):469-76. doi: 10.1093/jjco/hyq239. Epub 2011 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, 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. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.\n\nPURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with previously untreated stage II or stage III esophageal cancer that can be removed by surgery.', 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Determine whether neoadjuvant chemotherapy comprising oxaliplatin, floxuridine, docetaxel, and leucovorin calcium improves the rate of pathologic complete response in patients with previously untreated, resectable stage II or III adenocarcinoma of the esophagus.\n\nSecondary\n\n* Determine the progression-free and overall survival of patients treated with this regimen.\n* Determine the clinical response rates (complete response and partial response) in patients treated with this regimen.\n* Evaluate thymidylate synthase (TS), mRNA gene expression, TS activity, and TS and mRNA sequence, to determine the altered spots as related to drug resistance in these patients.\n* Evaluate the potential for genome-wide gene expression profiling to predict response to therapy, recurrence, progression-free survival, overall survival, and drug sensitivity and resistance in these patients.\n* Define the role of 5' untranslated region (5'-UTR) on translation and drug resistance in these patients.\n* Evaluate, by bone marrow aspirate analysis and flow cytometry, the initial presence of cancer cells in the marrow, and clearance of these cells after treatment with this regimen.\n* Evaluate the safety of this regimen in these patients.\n* Assess quality of life of patients during and after treatment with this regimen.\n\nOUTLINE: This is a nonrandomized, open-label study.\n\nPatients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV over 30 minutes, floxuridine IV over 24 hours, and leucovorin calcium IV over 24 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients undergo surgery after completion of chemotherapy. Patients who achieve pathologic complete response (pCR) receive no further chemotherapy. Patients who have not achieved a pCR receive 2 courses of adjuvant chemotherapy (same regimen as the neoadjuvant chemotherapy) beginning 3 weeks after surgery.\n\nPatients undergo blood and tissue collection periodically for correlative studies. Samples are analyzed for thymidylate synthase (TS), mRNA gene expression, TS activity, and TS and mRNA sequence by bone marrow aspirate, flow cytometry, and quantitative reverse transcriptase-polymerase chain reaction.\n\nQuality of life will be assessed at baseline, after neoadjuvant chemotherapy, after adjuvant therapy, and at the first 3-month follow-up visit.\n\nAfter completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 34 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of adenocarcinoma of the esophagus meeting the following criteria:\n\n * Stage II or III disease\n * Resectable disease\n * Previously untreated disease\n* No stage I (mucosal only) or stage IV (metastatic) disease\n\nPATIENT CHARACTERISTICS:\n\n* WBC \\> 3,000/mm\\^3\n* Absolute neutrophil count \\> 1,500/mm\\^3\n* Platelet count \\> 100,000/mm\\^3\n* Creatinine ≤ 2.0 mg/dL\n* Bilirubin \\< 2 times normal\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Must have central venous access\n* No other malignancy within the past 5 years\n* No concurrent medical or psychiatric problem that would preclude study treatment\n* No contraindications to paclitaxel\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy or radiotherapy to the esophagus\n* No oral cryotherapy (e.g., ice chips) on day 1 of each course'}, 'identificationModule': {'nctId': 'NCT00448760', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'A Nonrandomized Phase II Study: Feasibility and Outcome of Neo Adjuvant Chemotherapy With Oxaliplatin, Fluorodeoxyuridine (FUdR), Taxotere and Leucovorin in the Treatment of Previously Untreated Advanced Esophago-Gastric Carcinoma', 'orgStudyIdInfo': {'id': '20040006'}, 'secondaryIdInfos': [{'id': 'SCCC-2003151', 'type': 'OTHER', 'domain': 'University of Miami Sylvester Comprehensive Cancer Center'}, {'id': 'WIRB-20051464', 'type': 'OTHER', 'domain': 'Western Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant + Adjuvant Chemotherapy', 'interventionNames': ['Drug: Docetaxel', 'Drug: Floxuridine', 'Drug: Leucovorin', 'Drug: Oxaliplatin', 'Genetic: Microarray analysis', 'Genetic: reverse transcriptase-polymerase chain reaction', 'Procedure: Conventional surgery']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Intravenously, 25 mg/m2, over 30 minutes, 2 cycles', 'armGroupLabels': ['Neoadjuvant + Adjuvant Chemotherapy']}, {'name': 'Floxuridine', 'type': 'DRUG', 'otherNames': ['FUdR'], 'description': 'Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles', 'armGroupLabels': ['Neoadjuvant + Adjuvant Chemotherapy']}, {'name': 'Leucovorin', 'type': 'DRUG', 'description': 'Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles', 'armGroupLabels': ['Neoadjuvant + Adjuvant Chemotherapy']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Intravenously, 85 mg/m2, over 2 hours, 2 cycles', 'armGroupLabels': ['Neoadjuvant + Adjuvant Chemotherapy']}, {'name': 'Microarray analysis', 'type': 'GENETIC', 'description': 'Analysis of tumor for pathologic response to protocol therapy', 'armGroupLabels': ['Neoadjuvant + Adjuvant Chemotherapy']}, {'name': 'reverse transcriptase-polymerase chain reaction', 'type': 'GENETIC', 'description': 'Analysis of tumor for pathologic response to protocol therapy', 'armGroupLabels': ['Neoadjuvant + Adjuvant Chemotherapy']}, {'name': 'Conventional surgery', 'type': 'PROCEDURE', 'description': 'Surgical removal of tumor for correlative studies', 'armGroupLabels': ['Neoadjuvant + Adjuvant Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Sylvester Comprehensive Cancer Center - Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Bach Ardalan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Miami Sylvester Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}