Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT00064051
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2003-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C078157', 'term': '3-aminopyridine-2-carboxaldehyde thiosemicarbazone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2003-07-08', 'studyFirstSubmitQcDate': '2003-07-08', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (partial and complete response) as assessed by RECIST criteria'}], 'secondaryOutcomes': [{'measure': 'Progression-free and overall survival'}, {'measure': 'Safety and feasibility'}]}, 'conditionsModule': {'keywords': ['stage II pancreatic cancer', 'stage III pancreatic cancer', 'recurrent pancreatic cancer', 'stage IV pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug.\n\nPURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the objective response rate (partial and complete response) in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine.\n* Determine the progression-free interval and survival of patients treated with this regimen.\n* Determine the safety and feasibility of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\n* Stage I: Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n* Stage II: Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1, 8, and 15. Within 1 hour of completing 3-AP administration, patients receive gemcitabine IV over 30 minutes on days 2, 9, and 16. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed at 1 month, every 2 months for 6 months, and then every 3 months for 18 months.\n\nPROJECTED ACCRUAL: A total of 50-95 patients will be accrued for this study within 18-24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed pancreatic cancer\n\n * Unresectable or metastatic disease\n* Measurable disease\n\n * Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy\n* No CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 3 months\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 9 g/dL (transfusion allowed)\n\nHepatic\n\n* Bilirubin no greater than 2.0 mg/dL\n* AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases)\n* Chronic viral hepatitis allowed\n\nRenal\n\n* Creatinine no greater than 2.0 mg/dL\n\nCardiovascular\n\n* No myocardial infarction within the past 3 months\n* No uncontrolled congestive heart failure\n* No uncontrolled coronary artery disease\n* No uncontrolled arrhythmias\n\nPulmonary\n\n* No dyspnea at rest\n* No dependence on supplemental oxygen\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 study participation\n* No other malignancy except any of the following:\n\n * Carcinoma in situ of the cervix treated with cone biopsy or resection\n * Nonmetastatic basal cell or squamous cell skin cancer\n * Any stage I malignancy curatively resected more than 5 years ago\n* No active infection\n* No known or suspected glucose-6-phosphate dehydrogenase deficiency\n* No other concurrent life threatening illness\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed\n\nChemotherapy\n\n* No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior radiotherapy and recovered\n* No concurrent radiotherapy\n\nSurgery\n\n* More than 3 weeks since prior surgery and recovered\n\nOther\n\n* More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease\n* No other concurrent investigational drugs'}, 'identificationModule': {'nctId': 'NCT00064051', 'briefTitle': '3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'VION-CLI-031'}, 'secondaryIdInfos': [{'id': 'CDR0000306461', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}, {'name': 'triapine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Oncology Hematology Consultants', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Cancer Center at Centennial Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'B-9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Christie Hospital N.H.S. Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Foundation Trust - Surrey', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Mario Sznol, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vion Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vion Pharmaceuticals', 'class': 'INDUSTRY'}}}}