Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-28 @ 7:07 AM
Study NCT ID:
NCT00401635
Status:
COMPLETED
Last Update Posted:
2007-09-05
First Post:
2006-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal Doxorubicin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'lastUpdateSubmitDate': '2007-09-04', 'studyFirstSubmitDate': '2006-11-17', 'studyFirstSubmitQcDate': '2006-11-17', 'lastUpdatePostDateStruct': {'date': '2007-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (complete and partial responses)'}, {'measure': 'Toxicity'}]}, 'conditionsModule': {'keywords': ['advanced', 'recurrent', 'chemotherapy', 'first-line'], 'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '17486128', 'type': 'RESULT', 'citation': 'Pignata S, Scambia G, Pisano C, Breda E, Di Maio M, Greggi S, Ferrandina G, Lorusso D, Zagonel V, Febbraro A, Riva N, De Rosa V, Gallo C, Perrone F; Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies Group. A multicentre phase II study of carboplatin plus pegylated liposomal doxorubicin as first-line chemotherapy for patients with advanced or recurrent endometrial carcinoma: the END-1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies) group. Br J Cancer. 2007 Jun 4;96(11):1639-43. doi: 10.1038/sj.bjc.6603787. Epub 2007 May 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate activity and toxicity of the combination of carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or recurrent endometrial carcinoma.', 'detailedDescription': 'Treatment is planned with carboplatin AUC 5 given IV on day 1 and liposomal doxorubicin 40 mg/m2 given IV on day 1, with treatment repeated every 28 days. Delays in treatment administration and dose reductions have been planned according to toxicity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cytologic / histologic diagnosis of endometrial carcinoma\n* Indication for chemotherapy\n* Age 75 years or less\n* Life expectancy of at least 3 months\n* Measurable disease \\> 1 cm\n\nExclusion Criteria:\n\n* Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)\n* Performance status (ECOG) \\> 2\n* Previous chemotherapy treatment\n* Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia)\n* Leukocytes \\< 4000/mm3, platelets \\< 100000/mm3\n* Impaired renal function (creatinine \\> o = 1.25 times the upper normal limit) or liver function (SGOT or SGPT \\> o = 1.25 times the upper normal limit)\n* Present or suspected hemorrhagic syndromes\n* Uncooperative and/or unreliable patients\n* Patient's inability to access the center\n* Refusal of informed consent"}, 'identificationModule': {'nctId': 'NCT00401635', 'briefTitle': 'END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal Doxorubicin', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Naples'}, 'officialTitle': 'Phase II Multicentered Study of First-Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With the Combination of Carboplatin and Liposomal Doxorubicin', 'orgStudyIdInfo': {'id': 'END-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'liposomal doxorubicin', 'type': 'DRUG'}, {'name': 'carboplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '82100', 'city': 'Benevento', 'state': 'BN', 'country': 'Italy', 'facility': 'Ospedale Fatebenefratelli, U.O. di Oncologia', 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}, {'zip': '47100', 'city': 'Forlì', 'state': 'FO', 'country': 'Italy', 'facility': 'Ospedale Pierantoni, Divisione di Oncologia Medica', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'zip': '00186', 'city': 'Roma', 'state': 'Roma', 'country': 'Italy', 'facility': 'Ospedale S. Giovanni Calibita Fatebenefratelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Sandro Pignata, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}, {'name': 'Francesco Perrone, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Naples', 'class': 'OTHER'}}}}