[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453329":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":42,"responsibleParty":58,"collaborators":40,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":40,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":40,"enrollmentInfo":69,"targetDuration":40,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":44,"whyStopped":40,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Michigan Rogel Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal SMA (>7310 mm^2)","ACTIVE_COMPARATOR","Standard paclitaxel infusion time.",[13],"Drug: Paclitaxel",{"label":15,"type":16,"description":17,"interventionNames":18},"Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (\u003C5120 mm^2)","EXPERIMENTAL","Adjusted paclitaxel infusion time during only one dose; standard paclitaxel infusion time for all other doses.",[13],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Paclitaxel","Weekly intravenous (IV) infusion of a standard dose of paclitaxel 80 mg\u002Fm\\^2. Dose 1 is a 90-minute infusion. All other doses administered as a 1-hour infusion for a total of 12 weekly doses.",[9],[26],"Taxol",{"type":21,"name":22,"description":28,"armGroupLabels":29,"otherNames":30},"Weekly intravenous (IV) infusion of a standard dose of paclitaxel 80 mg\u002Fm\\^2. Dose 1 is a 90-minute infusion.\n\nDuring doses 2-12, patients with low SMA will receive one 2-hour infusion and patients with sarcopenic SMA will receive one 3-hour infusion. All other doses during weeks 2-12 are standard infusion time.",[15],[26],[32],{"name":33,"affiliation":5,"role":34},"Daniel L Hertz, PharmD, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Cancer AnswerLine","CONTACT","800-865-1125",null,"CancerAnswerLine@med.umich.edu",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-83.74088,42.27756,{"lat":54,"lon":53},[57],{"name":33,"role":34,"phone":40,"phoneExt":40,"email":40},{"type":59,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100453329","phase-4-pharmacokinetic-study-of-skeletal-muscle-area-based-paclitaxel-infusion-in-patients-with-cancer-100453329",false,"NCT05183126","Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer","Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer","Inclusion Criteria:\n\n* Planned paclitaxel 80 mg\u002Fm\\^2, 1-hour infusion\n* Evaluable computed tomography (CT) scan, positron emission tomography computed tomography (PET-CT) scan, or MRI scan (e.g. scan of the chest, abdomen, or pelvis for any indication w\u002Fin 1 year)\n* Female\n* ≥ 18 years old\n* Adequate organ function to receive paclitaxel treatment as defined in the protocol\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Concomitant administration of any moderate or strong inducer or inhibitor of CYP2C8, including rifampin or clopidogrel.\n* History of hypersensitivity reaction to paclitaxel or any components of paclitaxel (e.g., Cremophor EL) that precludes continued treatment with standard dose and infusion length\n* Pregnant or nursing\n* Receiving any other dose (i.e., not 80 mg\u002Fm2) or infusion rate (i.e., not 60 minute infusion) either due to toxicity during a previous cycle or any other reason","FEMALE","18 Years",{"count":70,"type":71},22,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low\u002Fsarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low\u002Fsarcopenic SMA normalizes the levels to those of patients with normal SMA.",[77,78,79],"Breast Cancer","Metastatic Gastric Cancer","Esophageal Cancer",[81],"pharmacokinetics","2026-07-01",{"date":84,"type":85},"2026-07-02","ACTUAL",{"date":87,"type":85},"2022-03-28",{"date":89,"type":71},"2026-11",{"name":5,"class":6},1]