Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-01 @ 12:34 AM
Study NCT ID:
NCT00026195
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2001-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irinotecan in Treating Aging Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-01', 'studyFirstSubmitDate': '2001-11-09', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'Up to 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Aging may affect the way these drugs work.\n\nPURPOSE: Phase I trial to determine the relationship between aging and the effectiveness of irinotecan in treating patients who have solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine whether there is a relationship between the pharmacokinetic characteristics of irinotecan and aging in patients with non-hematologic malignancies.\n* Determine whether there is a relationship between the toxic effects of this drug and aging in these patients.\n* Determine whether the relationship between genotype (UGT1A1, CYP3A, and other relevant genes) and phenotype (pharmacokinetics, toxicity) is affected by aging in these patients treated with this drug.\n* Analyze data collected on the co-morbid conditions and concurrent medications in these patients treated with this drug.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to age (18 to 55 vs 70 and over).\n\nPatients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 140 patients (70 per stratum) will be accrued for this study within 3.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed non-hematologic malignancy\n* Brain metastases or primary brain tumors are eligible provided patient is not receiving steroids or antiepileptic medications\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 55 or 70 and over\n\nPerformance status:\n\n* CTC 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* SGOT no greater than ULN\n\nRenal:\n\n* Creatinine no greater than ULN\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea)\n* No more than 1 prior chemotherapy regimen for metastatic disease (no limit if administered in the adjuvant setting)\n* No prior camptothecin\n\nEndocrine therapy:\n\n* See Disease Characteristics\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n* No concurrent radiotherapy, including for palliation\n\nSurgery:\n\n* At least 4 weeks since prior major surgery'}, 'identificationModule': {'nctId': 'NCT00026195', 'briefTitle': 'Irinotecan in Treating Aging Patients With Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Clinical Pharmacology In The Elderly: Prospective Evaluation Of The Pharmacokinetics, Pharmacogenetics And Pharmacodynamics Of CPT-11 And Aging', 'orgStudyIdInfo': {'id': 'CALGB-60001'}, 'secondaryIdInfos': [{'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CLB-60001'}, {'id': 'CDR0000068995', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'irinotecan', 'description': 'Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed for survival.', 'interventionNames': ['Drug: irinotecan hydrochloride']}], 'interventions': [{'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Rebecca and John Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143-0128', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20307-5000', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'CCOP - Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '60612-7323', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'MBCCOP - University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Chicago (Westside Hospital)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'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': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'CCOP - Northern Indiana CR Consortium', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '52242-1009', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Holden Comprehensive Cancer Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Marlene and Stewart Greenebaum Cancer Center, University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center - University Campus', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Minneapolis', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Columbia (Truman Memorial)', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ellis Fischel Cancer Center - Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Baptist Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198-7680', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'CCOP - Southern Nevada Cancer Research Foundation', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03756-0002', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Norris Cotton Cancer Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'CCOP - North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College of Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center, NY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York - Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Syracuse', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13217', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center, UNC', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Durham', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27104-4241', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CCOP - Southeast Cancer Control Consortium', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27157-1082', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital - Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Pennsylvania Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Lifespan: The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '05201', 'city': 'Bennington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Green Mountain Oncology Group', 'geoPoint': {'lat': 42.87813, 'lon': -73.19677}}, {'zip': '05401-3498', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Vermont Cancer Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '05009', 'city': 'White River Junction', 'state': 'Vermont', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - White River Junction', 'geoPoint': {'lat': 43.64896, 'lon': -72.31926}}, {'zip': '23298-0037', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'MBCCOP - Massey Cancer Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Stuart M. Lichtman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Don Monti Comprehensive Cancer Center at North Shore University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}