Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT00005861
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2000-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-08', 'lastUpdateSubmitDate': '2013-06-07', 'studyFirstSubmitDate': '2000-06-02', 'studyFirstSubmitQcDate': '2003-05-16', 'lastUpdatePostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage III endometrial carcinoma', 'stage IV endometrial carcinoma', 'recurrent endometrial carcinoma'], 'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '15975638', 'type': 'RESULT', 'citation': 'Homesley HD, Blessing JA, Sorosky J, Reid G, Look KY. Phase II trial of liposomal doxorubicin at 40 mg/m(2) every 4 weeks in endometrial carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2005 Aug;98(2):294-8. doi: 10.1016/j.ygyno.2005.05.016.'}]}, '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 II trial to study the effectiveness of liposomal doxorubicin in treating women who have recurrent, stage III, or stage IV endometrial cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer.\n* Determine the response rate, response duration, and overall survival of these patients treated with this regimen.\n\nOUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 2 years and then every 6 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage III, IV, or recurrent endometrial carcinoma for which curative radiotherapy or surgery is not an option\n* Bidimensionally measurable disease\n\n * Irradiated field as only site allowed if evidence of progression since radiotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* GOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* SGOT no greater than 3 times ULN\n* Alkaline phosphatase no greater than 3 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* LVEF normal by cardiac echocardiogram or MUGA\n\nOther:\n\n* No concurrent active infection\n* No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Prior chemotherapy as radiosensitizer allowed\n* No prior chemotherapy for advanced or metastatic disease\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* Recovered from prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n* Recovered from prior surgery\n\nOther:\n\n* No prior therapy that would preclude study\n* No other concurrent antineoplastic agents\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00005861', 'briefTitle': 'Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000067891'}, 'secondaryIdInfos': [{'id': 'GOG-0086M'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'pegylated liposomal doxorubicin hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '46202-5289', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242-1009', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Holden Comprehensive Cancer Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Medical Center Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '39216-4505', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'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': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Brookview Research, Inc.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Howard D. Homesley, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gynecologic Oncology Network'}, {'name': 'Paula M. Fracasso, MD, PhD', 'affiliation': 'Washington University Siteman Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}