Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT00695032
Status:
SUSPENDED
Last Update Posted:
2014-11-05
First Post:
2008-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D007069', 'term': 'Ifosfamide'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'lastUpdateSubmitDate': '2014-11-04', 'studyFirstSubmitDate': '2008-06-07', 'studyFirstSubmitQcDate': '2008-06-07', 'lastUpdatePostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of different biomarkers'}, {'measure': 'Sensitivity, specificity, and predictive value (positive and negative) of different markers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['renal toxicity', 'chemotherapeutic agent toxicity', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Chemotherapeutic Agent Toxicity', 'Renal Toxicity', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.\n\nPURPOSE: This research study is evaluating kidney damage in patients receiving cisplatin and ifosfamide for solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Identify and evaluate the early biomarkers of renal toxicity in patients with solid tumors treated with cisplatin and ifosfamide.\n\nSecondary\n\n* Correlate the modification of biomarker studies and blood concentrations of cisplatin.\n\nOUTLINE: Patients receive standard chemotherapy comprising cisplatin and/or ifosfamide.\n\nBlood and urine samples are collected on days 1 and 2 (or day 3 if receiving ifosfamide only) during the first 3 courses. Samples are analyzed to determine plasma concentrations of residual cisplatin and to obtain urinary-protein profiles to measure renal toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of a solid tumor\n\n * Any location allowed\n * Metastatic disease allowed\n* Planned treatment comprising cisplatin and/or ifosfamide as standard chemotherapy\n\nPATIENT CHARACTERISTICS:\n\nInclusion criteria:\n\n* Life expectancy \\> 3 months\n* Creatinine clearance ≥ 60 mL/min\n* Must be available for follow up\n* Not pregnant or nursing\n* Not under guardianship or in prison\n\nExclusion criteria:\n\n* Prior drug-related nephrotoxicity\n* Acute, uncontrolled urinary infection or \\> 48-hours\n* Pre-existing hemorrhagic cystitis\n* Weak bladder\n* Bilateral obstruction of urinary tract\n* Insufficient, severe bone marrow hypoplasia\n* Cardiorespiratory condition contraindicating hyperhydration\n* Hearing impairment\n* Hypersensitivity to cisplatin or products containing platinum\n* Major psychiatric condition (severe depression, psychosis, dementia)\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior yellow fever vaccine, live attenuated vaccine, or phenytoin\n* No concurrent participation in another biomedical study'}, 'identificationModule': {'nctId': 'NCT00695032', 'briefTitle': 'Kidney Damage in Patients Receiving Cisplatin and Ifosfamide for Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)', 'orgStudyIdInfo': {'id': '07GENE03'}, 'secondaryIdInfos': [{'id': 'ICREGAUD-TOXIPLAT'}, {'id': 'ICREGAUD-07-GENE-03'}, {'id': 'EUDRACT-2007-004251-12'}, {'id': 'INCA-RECF0479'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'ifosfamide', 'type': 'DRUG'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Christine Chevreau-Dalbianco, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Claudius Regaud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}