Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT00075504
Status:
COMPLETED
Last Update Posted:
2015-09-28
First Post:
2004-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005706', 'term': 'Gallbladder Neoplasms'}], 'ancestors': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C078157', 'term': '3-aminopyridine-2-carboxaldehyde thiosemicarbazone'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lescobar@montefiore.org', 'phone': '718-379-6866', 'title': 'Lisa Escobar-Peralta, Program Manager', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Stratum A Normal Liver Function Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV', 'otherNumAtRisk': 23, 'otherNumAffected': 22, 'seriousNumAtRisk': 23, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Stratum B Abnormal Liver Function Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 23, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Alkaline phosphatase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'seriousEvents': [{'term': 'Infection with normal ANC or Grade 1 or 2 Neutrophils: Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate According to RECIST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stratum A Normal Liver Function Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV'}, {'id': 'OG001', 'title': 'Stratum B Abnormal Liver Function Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance 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': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stratum A Normal Liver Function Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV'}, {'id': 'OG001', 'title': 'Stratum B Abnormal Liver Function Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '5.8'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '11.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years', 'description': "PFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stratum A Normal Liver Function Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV'}, {'id': 'OG001', 'title': 'Stratum B Abnormal Liver Function Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'comment': 'For stratum A the upper limit in the 95% CI for overall survival was not reached.', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': 'NA'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '26.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stratum A Normal Liver Function Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV'}, {'id': 'FG001', 'title': 'Stratum B Abnormal Liver Function Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'A total of 35 patients were enrolled from 7 institutions between December 2003 and August 2007', 'preAssignmentDetails': 'A total of 2 patients did not receive treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stratum A Normal Liver Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV'}, {'id': 'BG001', 'title': 'Stratum B Abnormal Liver Triapine, Gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days\n\ntriapine: Given IV\n\ngemcitabine: Given IV'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '85'}, {'value': '67.5', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '75'}, {'value': '62.3', 'groupId': 'BG002', 'lowerLimit': '35', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], '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': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2004-01-09', 'resultsFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2004-01-11', 'lastUpdatePostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-31', 'studyFirstPostDateStruct': {'date': '2004-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate According to RECIST Criteria', 'timeFrame': 'Up to 2 years', 'description': 'Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance 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': 'Progression Free Survival', 'timeFrame': 'Up to 2 years', 'description': "PFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression."}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stage II Gallbladder Cancer', 'Stage IIIA Gallbladder Cancer', 'Stage IIIB Gallbladder Cancer', 'Stage IVA Gallbladder Cancer', 'Stage IVB Gallbladder Cancer']}, 'referencesModule': {'references': [{'pmid': '20981545', 'type': 'RESULT', 'citation': 'Ocean AJ, Christos P, Sparano JA, Matulich D, Kaubish A, Siegel A, Sung M, Ward MM, Hamel N, Espinoza-Delgado I, Yen Y, Lane ME. Phase II trial of the ribonucleotide reductase inhibitor 3-aminopyridine-2-carboxaldehydethiosemicarbazone plus gemcitabine in patients with advanced biliary tract cancer. Cancer Chemother Pharmacol. 2011 Aug;68(2):379-88. doi: 10.1007/s00280-010-1481-z. Epub 2010 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with unresectable or metastatic bile duct or gallbladder cancer. Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more cancer cells by making them more sensitive to the drug.', 'detailedDescription': 'OBJECTIVES:\n\nI. To determine the objective response rates for the combination of triapine and gemcitabine in patients with primary tumors of the biliary ducts and gall bladder.\n\nII. To assess the toxicities and recovery from toxicities for patients with biliary duct and gall bladder tumors treated with the combination of triapine and gemcitabine.\n\nIII. To determine the survival and progression free survival of patients with biliary and gall bladder tumors treated with the combination of triapine and gemcitabine.\n\nOUTLINE: This is a non-randomized, multicenter study. Patients are stratified according to bilirubin levels (normal vs abnormal).\n\nPatients receive 3-AP (Triapine) IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 1 additional course beyond CR.\n\nPatients are followed every 3 months for up to 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the biliary ducts that is unresectable and/or metastatic; this can include unresectable or metastatic carcinomas of the Ampulla of Vater. In addition, unresectable or metastatic gall bladder carcinoma will be allowed\n* Measurable disease\n* No prior chemotherapy\n* Life expectancy of greater than 3 months\n* ECOG performance status =\\< 2 (Karnofsky \\>= 60%)\n* Leukocytes \\>= 3,000/uL\n* Absolute neutrophil count \\>= 1,500/uL\n* Platelets \\>= 100,000/uL\n* Creatinine within normal institutional limits\n* Patients may have mildly abnormal liver function defined as a total bilirubin \\> ULN and =\\< 3x the institutional upper limits of normal (includes CTCAE v.3 grades 1-2 hyperbilirubinemia)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients may not be receiving any other investigational agents\n* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Triapine or gemcitabine\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia\n* Uncontrolled pulmonary disease including asthma, chronic bronchitis and COPD or with requirements for chronic oxygen use\n* Pregnant or lactating women\n* HIV infection\n* Patients with G6PD deficiency will be excluded in view of the potential for methemoglobinemia\n* Psychiatric illness/social situations that would limit compliance with study requirements'}, 'identificationModule': {'nctId': 'NCT00075504', 'briefTitle': 'Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder', 'orgStudyIdInfo': {'id': 'NCI-2012-03030'}, 'secondaryIdInfos': [{'id': '6254', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U01CA062505', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062505', 'type': 'NIH'}, {'id': 'N01CM62204', 'link': 'https://reporter.nih.gov/quickSearch/N01CM62204', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'triapine, gemcitabine', 'description': 'Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days', 'interventionNames': ['Drug: triapine', 'Drug: gemcitabine']}], 'interventions': [{'name': 'triapine', 'type': 'DRUG', 'otherNames': ['3-AP', 'OCX-191'], 'description': 'Given IV', 'armGroupLabels': ['triapine, gemcitabine']}, {'name': 'gemcitabine', 'type': 'DRUG', 'otherNames': ['dFdC', 'difluorodeoxycytidine hydrochloride', 'Gemzar'], 'description': 'Given IV', 'armGroupLabels': ['triapine, gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467-2490', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Allyson Ocean', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}