Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 4:57 AM
Study NCT ID:
NCT00021034
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'C012566', 'term': 'taurolidine'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2001-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2001-07-11', 'studyFirstSubmitQcDate': '2004-02-13', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage II ovarian epithelial cancer', 'stage III ovarian epithelial cancer', 'stage IV ovarian epithelial cancer', 'recurrent ovarian epithelial cancer', 'fallopian tube cancer', 'primary peritoneal cavity cancer'], 'conditions': ['Fallopian Tube Cancer', 'Ovarian Cancer', 'Primary Peritoneal Cavity Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase I trial to study the effectiveness of taurolidine in treating patients who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.', 'detailedDescription': 'OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of taurolidine after positive second-look surgery in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. II. Determine the dose-limiting toxicity and safety of this drug in these patients.\n\nOUTLINE: This is a dose-escalation study. Patients receive taurolidine intraperitoneally weekly on weeks 1-3 and 7-9 in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of taurolidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 weeks for 9 weeks.\n\nPROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study within 12-18 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal adenocarcinoma Stage IIC or higher at diagnosis Successfully received prior chemotherapy Undergone initial cytoreductive surgery Evidence of gross disease at second-look surgery\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST and/or ALT less than 3 times upper limit of normal No clinically significant PT/PTT abnormality Renal: Creatinine less than 1.7 mg/dL Other: No known hypersensitivity to taurolidine or its excipients No other clinically significant disease that would preclude study\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 30 days since prior investigational drugs'}, 'identificationModule': {'nctId': 'NCT00021034', 'briefTitle': 'Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Phase I Trial of Taurolidine After Positive Second Look Surgery for Recurrent Ovarian Epithelial, Fallopian Tube and Primary Peritoneal Cancers', 'orgStudyIdInfo': {'id': '01-020'}, 'secondaryIdInfos': [{'id': 'CDR0000068740', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-G01-1976'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'chemotherapy', 'type': 'DRUG'}, {'name': 'taurolidine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Paul Sabbatini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}