[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05183126":3,"trial-entities:NCT05183126":100,"trial-summary:NCT05183126":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":45,"secondary_outcomes":50,"sex":57,"minimum_age":58,"maximum_age":15,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":74,"locations":77,"central_contacts":90,"overall_officials":96,"references":98,"see_also_links":99},"NCT05183126","UMCC 2021.109","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","RECRUITING","2026-11","2026-07","2026-07-02","2022-03-28","University of Michigan Rogel Cancer Center","OTHER",null,"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.","Paclitaxel is an FDA-approved and commonly used standard of care agent for patients with early-stage breast cancer. This study will use the standard dose of 80 mg\u002Fm\\^2, including the typical pre-medications as per University of Michigan Rogel Cancer Center institutional standard. The only investigational component of this study is lengthening the infusion duration from 1-hour to 2 or 3 hours for a single dose in patients with low SMA.\n\nJAN2025 update, Paclitaxel is an FDA-approved and commonly used standard of care agent for patients with early-stage breast cancer or metastatic gastric or esophageal cancers.",[19,20,21],"Breast Cancer","Metastatic Gastric Cancer","Esophageal Cancer",[23],"pharmacokinetics","INTERVENTIONAL","TREATMENT",[27],"PHASE4",{"count":29,"type":30},22,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"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.",[37],"Normal SMA (>7310 mm^2)",[39],"Taxol",{"type":33,"name":34,"description":41,"armGroupLabels":42,"otherNames":44},"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.",[43],"Low SMA (5120 - 7310 mm^2) and Sarcopenic SMA (\u003C5120 mm^2)",[39],[46],{"measure":47,"description":48,"timeFrame":49},"Maximum concentration (Cmax) of paclitaxel plasma","Compare Cmax in patients with lower SMA with an adjusted infusion duration (i.e., 2-hour or 3-hour) to that of patients with normal SMA receiving standard 1-hour infusion. Blood samples for pharmacokinetic analysis will be collected within 5 minutes prior to the end of SMA-based and standard paclitaxel infusions. Measurement of plasma paclitaxel concentration for Cmax will be conducted using a liquid chromatography\u002Fmass spectroscopy assay.","Up to week 12",[51,54],{"measure":52,"description":53,"timeFrame":49},"Two- to three-hour Cmax vs. one-hour Cmax in low SMA patients","To compare Cmax in patients with lower SMA when receiving adjusted infusion duration (i.e., 2-hour or 3-hour) versus standard 1-hour infusion. Blood samples for pharmacokinetic analysis will be collected within 5 minutes prior to the end of SMA-based and standard paclitaxel infusions. Measurement of plasma paclitaxel concentration for Cmax will be conducted using a liquid chromatography\u002Fmass spectroscopy assay.",{"measure":55,"description":56,"timeFrame":49},"One-hour Cmax in normal SMA patients vs. one-hour Cmax in low SMA patients","To compare Cmax in patients with lower SMA versus patients with normal SMA receiving when both receive standard 1-hour infusion. Blood samples for pharmacokinetic analysis will be collected within 5 minutes prior to the end of standard 1-hour paclitaxel infusions in both groups. Measurement of plasma paclitaxel concentration for Cmax will be conducted using a liquid chromatography\u002Fmass spectroscopy assay.","FEMALE","18 Years",false,{"inclusion":61,"exclusion":68,"raw_text":73},[62,63,64,65,66,67],"Planned paclitaxel 80 mg\u002Fm\\^2, 1-hour infusion","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)","Female","≥ 18 years old","Adequate organ function to receive paclitaxel treatment as defined in the protocol","Ability to understand and the willingness to sign a written informed consent",[69,70,71,72],"Concomitant administration of any moderate or strong inducer or inhibitor of CYP2C8, including rifampin or clopidogrel.","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","Pregnant or nursing","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","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",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":13,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":87},"Ann Arbor","Michigan","48109","United States",[84],{"name":85,"role":86},"Daniel L Hertz, PharmD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},42.27756,-83.74088,[91],{"name":92,"role":93,"phone":94,"email":95},"Cancer AnswerLine","CONTACT","800-865-1125","CancerAnswerLine@med.umich.edu",[97],{"name":85,"affiliation":13,"role":86},[],[],{"nct_id":4,"conditions":101,"biomarkers":105},[102,103,104],"Breast Carcinoma","Esophageal Carcinoma","Gastric Carcinoma",[],{"nct_id":4,"found":107,"summary":108,"prompt_version":118},true,{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an interventional study with a planned enrollment of 22 participants. It will compare different paclitaxel infusion durations.","completed","Paclitaxel Infusion Study for Breast, Gastric, and Esophageal Cancers","This study is looking at how the chemotherapy drug paclitaxel (an FDA-approved treatment for breast, metastatic gastric, and esophageal cancers) is processed in the body. Specifically, it aims to see if changing the infusion time for paclitaxel can help patients with lower skeletal muscle area (SMA) achieve similar drug levels as those with normal SMA. You might be eligible if you are an adult woman with one of these cancers and are planned to receive paclitaxel. The study will measure the highest level of paclitaxel in your blood to see if longer infusion times help normalize these levels. The current recruitment status is unclear.","The primary measurement of paclitaxel levels will be taken up to week 12.",104,"You would receive weekly intravenous infusions of paclitaxel for a total of 12 weeks. For one dose (between doses 2-12), your infusion time might be lengthened to 2 or 3 hours.","Not stated in the trial record.",[34],"v2"]