Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-29 @ 1:35 PM
Study NCT ID:
NCT01426633
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2011-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007890', 'term': 'Leiomyosarcoma'}, {'id': 'D008080', 'term': 'Liposarcoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077606', 'term': 'Trabectedin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004149', 'term': 'Dioxoles'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-15', 'studyFirstSubmitDate': '2011-08-29', 'studyFirstSubmitQcDate': '2011-08-30', 'lastUpdatePostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the maximum tolerated dose (MTD) of the combination of gemcitabine and trabectedin (Yondelis®) in patients with advanced and/or metastatic leiomyosarcoma and liposarcoma.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'To assess the recommended phase II dose (RPTD) of the combination of gemcitabine and trabectedin (Yondelis®) in patients with advanced and/or metastatic leiomyosarcoma and liposarcoma.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['L-sarcomas'], 'conditions': ['Leiomyosarcoma', 'Liposarcoma']}, 'referencesModule': {'references': [{'pmid': '25591040', 'type': 'DERIVED', 'citation': 'Kasper B, Reichardt P, Pink D, Sommer M, Mathew M, Rauch G, Hohenberger P. Combination of trabectedin and gemcitabine for advanced soft tissue sarcomas: results of a phase I dose escalating trial of the German Interdisciplinary Sarcoma Group (GISG). Mar Drugs. 2015 Jan 13;13(1):379-88. doi: 10.3390/md13010379.'}]}, 'descriptionModule': {'briefSummary': 'L-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas and 12 % leiomyosarcomas). Approval for the induction of trabectedin into the treatment armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure with anthracyclines and/or ifosfamide depended mainly on its activity in the L-sarcomas (Garcia-Carbonero 2004, Le Cesne 2005, and Demetri 2009). Significant activity has been described for the use of gemcitabine and especially the combination of gemcitabine and docetaxel mainly in leiomyosarcomas and liposarcomas (Maki 2007). However, the combination of gemcitabine and docetaxel is associated with significant toxicity. Pulmonary toxicity and refractory peripheral oedema are the most common severe adverse events. The aim of the present phase I study will be to examine safety data of this promising treatment combination of gemcitabine and trabectedin in L-sarcomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with histologically confirmed L-sarcomas (leiomyosarcoma and liposarcoma)\n* Measurable disease according to RECIST 1.1\n* Any treatment line except adjuvant setting: evidence of primary metastatic situation or disease progression within the last 6 months (based on RECIST 1.1) in computed tomography or magnetic resonance imaging\n* Any prior treatment possible\n* Age \\>= 18 years\n* WHO PS =\\< 1\n* Effective contraception during study medication and up to 3 months from treatment discontinuation\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Surgical intervention \\< 4 weeks\n* Pregnancy or lactation\n* Known allergic reaction to trabectedin or gemcitabine or one of their components\n* The following laboratory values:\n\nAbsolute neutrophil count \\< 1.5 x 103/mm3 Platelets \\< 100.000/mm3 Hb \\< 9 g/dL Serum creatinine \\>= 2.5 mg/dl SGOT and/or SGPT and/or alkaline phosphatase and/or CPK \\> 2.5 x ULN Total bilirubin \\> 1 x ULN except in the case of Gilbert's syndrome\n\n* Participation in another study (four weeks before and during the study)\n* Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix"}, 'identificationModule': {'nctId': 'NCT01426633', 'briefTitle': 'Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Phase I Dose Escalating Trial Evaluating the Combination of Gemcitabine and Trabectedin in Patients With Advanced and/or Metastatic Leiomyosarcoma or Liposarcoma', 'orgStudyIdInfo': {'id': 'GISG-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcitabine + Trabectedin', 'interventionNames': ['Drug: Gemcitabine + Trabectedin']}], 'interventions': [{'name': 'Gemcitabine + Trabectedin', 'type': 'DRUG', 'description': 'Combination therapy of gemcitabine and trabectedin', 'armGroupLabels': ['Gemcitabine + Trabectedin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Mannheim University Medical Center', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Bernd Kasper, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Heidelberg, Mannheim University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Bernd Kasper', 'investigatorAffiliation': 'Heidelberg University'}}}}