Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
Study NCT ID:
NCT01100359
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2010-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposome-Encapsulated Doxorubicin Citrate and Carboplatin in Treating Patients With Advanced or Metastatic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2010-04-07', 'studyFirstSubmitQcDate': '2010-04-07', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate'}], 'secondaryOutcomes': [{'measure': 'Duration of progression-free survival'}, {'measure': 'Overall survival'}, {'measure': 'Safety'}, {'measure': 'Feasibility'}]}, 'conditionsModule': {'keywords': ['endometrial clear cell carcinoma', 'recurrent endometrial carcinoma', 'stage IIIA endometrial carcinoma', 'stage IIIB endometrial carcinoma', 'stage IIIC endometrial carcinoma', 'stage IVA endometrial carcinoma', 'stage IVB endometrial carcinoma'], 'conditions': ['Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.\n\nPURPOSE: This phase II trial is studying how well liposome-encapsulated doxorubicin citrate given together with carboplatin works in treating patients with advanced or metastatic recurrent endometrial cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To assess activity of the combination of liposome-encapsulated doxorubicin citrate and carboplatin in patients with primary advanced or metastatic recurrent carcinoma of the endometrium.\n\nSecondary\n\n* To assess the toxicity and feasibility of this regimen in these patients.\n* To determine the progression-free survival and overall survival of these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive liposome-encapsulated doxorubicin citrate IV over 1 hour followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6-9 courses in the absence of disease progression or unacceptable toxicity.\n\nTissue array and immunohistochemistry analysis are conducted on paraffin-embedded tumor blocks of the primarily operated tissue of all patients for different markers (e.g., progesterone-/estrogen receptor, HER2-receptor, soluble L1-molecule, Topo 2a) to examine tumor characteristics.\n\nQuality of life is assessed at baseline, during study treatment, at completion of study treatment, and then at 1 year after completion of study treatment.\n\nAfter completion of study therapy, patients are followed up every 3 months for 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of endometrial carcinoma, including any of the following cellular types:\n\n * Mixed Mullerian carcinoma\n * Serous carcinoma\n * Clear cell carcinoma\n* Primary advanced (FIGO stage III or stage IV) or metastatic recurrent disease\n* Disease not curable by surgery\n* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm with spiral CT scan or MRI\n* No known cerebral metastases\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Life expectancy ≥ 12 weeks\n* Platelet count ≥ 100,000/mm\\^3\n* ANC ≥ 1,500/mm\\^3\n* Hemoglobin ≥ 10 g/dL\n* Creatinine ≤ 1.25 times upper limit of normal (ULN)\n* Bilirubin ≤ 1.25 times ULN\n* AST/ALT \\< 3 times ULN\n* Glomerular filtration rate ≥ 50 mL/min\n* LVEF ≥ 50% by ECHO\n* Fertile patients must use effective contraception\n* No myocardial infarction within the past 6 months\n* No NYHA class II-IV congestive heart failure\n* No third degree or complete heart block unless a pacemaker is in place\n* No other malignancy within the past 5 years\n* No concomitant medical illness (e.g., uncontrolled infection, uncontrolled angina, or other relevant illness) that makes the prescribed treatments within this study unfeasible\n* No known hypersensitivity to study drugs\n* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy for disease recurrence\n* At least 12 months since prior adjuvant therapy containing anthracyclines with cumulative doses not exceeding the following:\n\n * Epirubicin 600 mg/m²\n * Doxorubicin 300 mg/m²\n* At least 6 months since prior adjuvant therapy containing platinum\n* At least 4 weeks since completion of radiotherapy involving the whole pelvis\n* No concurrent radiotherapy or planned radiotherapy after study\n* No concurrent endocrine, immunological, or other anticancer therapy\n* No concurrent participation in another investigational drug study'}, 'identificationModule': {'nctId': 'NCT01100359', 'briefTitle': 'Liposome-Encapsulated Doxorubicin Citrate and Carboplatin in Treating Patients With Advanced or Metastatic Recurrent Endometrial Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Multicenter Trial of the Austrian AGO With the Combination of Liposomal Doxorubicin (Myocet®) and Carboplatin in Primary Advanced or Metastatic and Recurrent Endometrial Cancer', 'orgStudyIdInfo': {'id': 'MUI-AGO-15'}, 'secondaryIdInfos': [{'id': 'CDR0000669712', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EUDRACT-2007-004060-40'}, {'id': 'EU-21027'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'liposome-encapsulated doxorubicin citrate', 'type': 'DRUG'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'email': 'Christian.marth@i-med.ac.at', 'phone': '43-512-504-23050'}], 'facility': 'Innsbruck Universitaetsklinik', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Christian Marth, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University Innsbruck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}}}}