Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 10:10 AM
Study NCT ID:
NCT00003135
Status:
UNKNOWN
Last Update Posted:
2009-04-30
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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': 'D000291', 'term': 'Adnexal 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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '1997-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2009-04-29', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2009-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor response'}, {'measure': 'Toxicity'}]}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer', 'recurrent cervical cancer', 'stage IVB cervical cancer', 'stage IVA cervical cancer', 'stage IV ovarian epithelial cancer', 'recurrent ovarian epithelial cancer', 'stage IV endometrial carcinoma', 'recurrent endometrial carcinoma', 'stage IV ovarian germ cell tumor', 'recurrent ovarian germ cell tumor', 'male breast cancer'], 'conditions': ['Breast Cancer', 'Cervical Cancer', 'Endometrial Cancer', 'Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hyperthermia may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving fluorouracil and liposomal doxorubicin together with systemic hyperthermia works in treating patients with metastatic breast, ovarian, endometrial, or cervical cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Evaluate tumor response and toxicity induced by fluorouracil and doxorubicin HCl liposome combined with mild systemic hyperthermia in patients with metastatic breast, ovarian, endometrial, or cervical cancer.\n\nOUTLINE: This is a time-escalation study of systemic hyperthermia.\n\nPatients receive fluorouracil IV continuously over 24 hours on days 1-5 and doxorubicin HCl liposome IV over 30 minutes on day 6. Beginning on day 7, patients receive heat applied for 6-24 hours (in 6-hour sequential treatments) using a mild hyperthermia-induction device. Treatment repeats every 4-5 weeks for a total of 4 courses. Patients who achieve less than a complete response but have no disease progression may receive additional courses of chemotherapy alone.\n\nCohorts of 5 patients receive escalating durations of hyperthermia until the recommended phase II duration is determined. The recommended phase II duration of hyperthermia is defined as the level preceding that at which 1 of 5 patients experiences measurable toxicity. (Phase I closed as of 9/28/01)\n\nPatients are followed at 4 weeks and then every 6 months for 1 year.\n\nPROJECTED ACCRUAL: A maximum of 34 patients will be accrued for this study within 48 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic breast, ovarian, endometrial, or cervical carcinoma\n* Measurable and evaluable disease\n* No brain metastases\n* No hepatic involvement greater than 80%\n* No lung involvement greater than 30%\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nSex:\n\n* Not specified\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* Zubrod 0-2\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* Absolute granulocyte count greater than 1,500/mm\\^3\n* Platelet count greater than 90,000/mm\\^3\n* Normal bone marrow cellularity on bone marrow biopsy\n* Thrombin time less than 17 sec\n* Fibrinogen greater than 200 mg/dL\n* FSP less than 40\n* No coagulopathy\n\nHepatic:\n\n* Bilirubin less than 2.0 mg/dL\n* SGPT less than 2 times normal\n* PT less than 14 sec\n* PTT less than 35 sec\n\nRenal:\n\n* BUN less than 25 mg/dL\n* Creatinine clearance at least 45 mL/min\n\nCardiovascular:\n\n* Normal cardiovascular system\n* Resting ventricular ejection fraction greater than 40%\n* No prior myocardial infarction\n* No symptomatic coronary artery disease\n* No unstable blood pressure\n* No thromboembolic disease\n\nNeurologic:\n\n* No seizures or other CNS disorders\n* Negative computerized tomographic scan of brain\n\nPulmonary:\n\n* FEV\\_1 greater than 70% of predicted\n* Arterial pressure of oxygen greater than 60 mmHg on room air with appropriate pressure of carbon dioxide and pH values\n* No history of cardiopulmonary or respiratory disease\n\nOther:\n\n* No other serious concurrent medical illness\n* No diabetes mellitus\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Prior chemotherapy allowed\n\nEndocrine therapy:\n\n* No adrenal corticosteroids\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent cardiac glycosides, antianginal therapy, or antiarrhythmics\n* No concurrent vasodilators, anticoagulants, thrombolytic agents, or aspirin'}, 'identificationModule': {'nctId': 'NCT00003135', 'briefTitle': 'Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy', 'orgStudyIdInfo': {'id': 'CDR0000065903'}, 'secondaryIdInfos': [{'id': 'UTHSC-MS-96205'}, {'id': 'NCI-V97-1356'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'pegylated liposomal doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'hyperthermia treatment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77225', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joan M.C. Bull, MD', 'role': 'CONTACT', 'email': 'joan.m.bull@uth.tmc.edu', 'phone': '713-500-6820'}], 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Joan M.C. Bull, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Joan M.C. Bull', 'oldOrganization': 'University of Texas Health Science Center at Houston'}}}}