Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-21 @ 4:08 PM
Study NCT ID:
NCT00001495
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, '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': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1999-09', 'completionDateStruct': {'date': '2000-10'}, 'lastUpdateSubmitDate': '2008-03-03', 'studyFirstSubmitDate': '1999-11-03', 'studyFirstSubmitQcDate': '2002-12-09', 'lastUpdatePostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-12-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Camptothecin', 'Cancer', 'Chemotherapy', 'Natural Products', 'Neoplasms'], 'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '1653362', 'type': 'BACKGROUND', 'citation': 'Negoro S, Fukuoka M, Masuda N, Takada M, Kusunoki Y, Matsui K, Takifuji N, Kudoh S, Niitani H, Taguchi T. Phase I study of weekly intravenous infusions of CPT-11, a new derivative of camptothecin, in the treatment of advanced non-small-cell lung cancer. J Natl Cancer Inst. 1991 Aug 21;83(16):1164-8. doi: 10.1093/jnci/83.16.1164.'}, {'pmid': '8044782', 'type': 'BACKGROUND', 'citation': 'de Forni M, Bugat R, Chabot GG, Culine S, Extra JM, Gouyette A, Madelaine I, Marty ME, Mathieu-Boue A. Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res. 1994 Aug 15;54(16):4347-54.'}]}, 'descriptionModule': {'briefSummary': 'This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.', 'detailedDescription': 'Irinotecan (CPT-11) is a promising camptothecin analogue with activity in solid tumors. In Phase I studies using short intravenous infusion schedules, the predominant drug toxicities have been gastrointestinal, such as diarrhea, and myelosuppression. In animal studies, prolonged infusion schedules followed by short drug-free intervals have resulted in preservation of antitumor activity and decreased drug toxicity. Therefore, we propose to examine a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen. The duration of these treatments will be escalated in our Phase I study until patients are receiving therapy for 2 out of every 3 weeks. Standard Phase I drug toxicity and tumor response information will be monitored and the pharmacokinetics of irinotecan and its active metabolite, SN-38 will also be examined. We will also attempt to monitor the intracellular molecular effects of SN-38 therapy in blood, bone marrow, and, whenever possible, tumor tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\nRecurrent or metastatic cancer, including lymphoma.\n\nNo leukemia.\n\nNo active CNS disease.\n\nRefractory to all effective therapy OR No effective therapy exists.\n\nMeasurable disease not required.\n\nPRIOR/CONCURRENT THERAPY:\n\nBiologic Therapy: Greater than 4 weeks and recovered from immunotherapy.\n\nChemotherapy: Greater than 4 weeks and recovered from chemotherapy.\n\nPrevious therapy with irinotecan is permitted.\n\nEndocrine Therapy: Not specified.\n\nRadiotherapy: Greater than 4 weeks since radiotherapy.\n\nSurgery: Recovered from prior surgery.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: ECOG 0-2.\n\nHematopoietic: AGC greater than 1,500.\n\nPlatelets greater than 100,000.\n\nHepatic: Bilirubin no greater than 1.5 mg/dL.\n\nAST no greater than 2 times normal.\n\nRenal: Creatinine no greater than 1.5 mg/dL.\n\nOTHER:\n\nHIV negative.\n\nNo active infection requiring antibiotics.\n\nNo concurrent medical illness that would interfere with chemotherapy.\n\nNo pregnant or nursing women.\n\nAdequate contraception required of fertile patients.\n\nImaging/exams for tumor measurement within 28 days prior to registration.'}, 'identificationModule': {'nctId': 'NCT00001495', 'briefTitle': 'A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Phase I Study of Irinotecan (CPT-11) Administered as a Prolonged Infusion in Adult Patients With Solid Tumors', 'orgStudyIdInfo': {'id': '960013'}, 'secondaryIdInfos': [{'id': '96-C-0013'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'irinotecan (CPT-11)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute (NCI)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}