Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
Study NCT ID:
NCT00248560
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2005-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], '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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sukaria@karmanos.org', 'phone': '313-576-8751', 'title': 'Ammar Sukari, M.D.', 'organization': 'Barbara Ann Karmanos Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial design was changed during accrual to allow for study continuation although response rate was lower than predicted. The trial was completed but it did not meet the specified end points.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Gemcitabine, Docetaxel', 'description': 'Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.', 'otherNumAtRisk': 36, 'otherNumAffected': 33, 'seriousNumAtRisk': 36, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 4.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Fluid Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Fluid Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 3.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response (Complete Response [CR] + Partial Response [PR])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine, Docetaxel', 'description': 'Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.32', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'every 8 weeks for approximately 8 - 48 weeks', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine, Docetaxel', 'description': 'Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.\n\ndocetaxel: Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.\n\nGemcitabine: Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '6.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 8 weeks', 'description': 'Response duration in months', 'unitOfMeasure': 'months', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those patients that have a recorded CR or PR'}, {'type': 'SECONDARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine, Docetaxel', 'description': 'Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 8 weeks', 'description': 'Overall Survival using the Kaplan-Meier method', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Toxicity as Measured by Number and Grade of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine, Docetaxel', 'description': 'Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Hyponatremia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Syncope', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fluid retention', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Mucositis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other non-hematologic toxicity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 2 weeks', 'description': 'Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gemcitabine, Docetaxel', 'description': 'Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gemcitabine, Docetaxel', 'description': 'Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'spread': '8.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', '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': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2005-11-03', 'resultsFirstSubmitDate': '2014-08-18', 'studyFirstSubmitQcDate': '2005-11-03', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-18', 'studyFirstPostDateStruct': {'date': '2005-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response (Complete Response [CR] + Partial Response [PR])', 'timeFrame': 'every 8 weeks for approximately 8 - 48 weeks', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}], 'secondaryOutcomes': [{'measure': 'Response Duration', 'timeFrame': 'Every 8 weeks', 'description': 'Response duration in months'}, {'measure': 'Survival', 'timeFrame': 'Every 8 weeks', 'description': 'Overall Survival using the Kaplan-Meier method'}, {'measure': 'Toxicity as Measured by Number and Grade of Adverse Events', 'timeFrame': 'Every 2 weeks', 'description': 'Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'recurrent squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the larynx', 'recurrent squamous cell carcinoma of the lip and oral cavity', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'metastatic squamous neck cancer with occult primary squamous cell carcinoma', 'recurrent metastatic squamous neck cancer with occult primary', 'recurrent squamous cell carcinoma of the nasopharynx', 'stage IV squamous cell carcinoma of the nasopharynx', 'recurrent squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.gov/clinicaltrials', 'label': "Clinical trial summary from the National Cancer Institute's PDQ® database"}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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 gemcitabine together with docetaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the response rate in patients with previously treated persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and docetaxel.\n\nSecondary\n\n* Determine the toxicity of this regimen in these patients.\n* Determine the duration of response and survival of patients treated with this regimen.\n\nOUTLINE: Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 60 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses of therapy beyond documentation of CR.\n\nAfter completion of study treatment, patients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 17-41 patients will be accrued within 42-49 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed squamous cell carcinoma of the head and neck\n* Metastatic, persistent, or recurrent disease\n* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan\n* Must have had definitive surgery and/or radiation therapy AND received at least 1, but no more than 2, chemotherapy regimens, either given as primary therapy or adjuvant therapy before or after surgery and/or radiotherapy\n* No active or prior CNS metastasis\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* SWOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Granulocyte count \\> 1,500/mm\\^3\n* Hemoglobin ≥ 8 g/dL\n* Platelet count \\> 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin normal\n* Meets 1 of the following criteria:\n\n * Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)\n * AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN\n * AP ≤ 5 times ULN AND AST or ALT normal\n\nRenal\n\n* Creatinine \\< 1.5 mg/dL\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment\n* No peripheral neuropathy ≥ grade 2\n* No active infection requiring systemic therapy\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or any other site\n* No history of severe hypersensitivity reaction to study drugs or other drugs formulated with polysorbate 80\n* No other serious condition that would preclude study treatment\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n* No prior taxane or gemcitabine\n* At least 4 weeks since prior chemotherapy and recovered\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy and recovered\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* No other concurrent therapy for this disease'}, 'identificationModule': {'nctId': 'NCT00248560', 'briefTitle': 'Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Barbara Ann Karmanos Cancer Institute'}, 'officialTitle': 'Phase II Study of Gemcitabine and Docetaxel (GEMDOC) Combination in Patients With Previously Treated Recurrent or Metatstatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)', 'orgStudyIdInfo': {'id': 'CDR0000445589'}, 'secondaryIdInfos': [{'id': 'P30CA022453', 'link': 'https://reporter.nih.gov/quickSearch/P30CA022453', 'type': 'NIH'}, {'id': 'WSU-D-2830'}, {'id': 'WSU-HIC-120904M1F'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcitabine, docetaxel', 'description': 'Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.', 'interventionNames': ['Drug: docetaxel', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.', 'armGroupLabels': ['Gemcitabine, docetaxel']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': 'Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.', 'armGroupLabels': ['Gemcitabine, docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201-1379', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Ammar Sukari, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barbara Ann Karmanos Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barbara Ann Karmanos Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ammar Sukari', 'investigatorAffiliation': 'Barbara Ann Karmanos Cancer Institute'}}}}