None listed
Conditions
Interventions
Drug : Study drug: Herzuma® + paclitaxel
• Paclitaxel: 175mg/m2 + D5W 500mL miv over 3hr (with filter) at D1 q 3weeks (upto 6 cycles)
• Hezuma®: 8mg/kg (first cycle loading, then 6mg/kg at 2nd or mor
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)? Have histologically proven urothelial carcinoma. 2)? Be = 20 years of age on the day of signing the informed consent. 3)? Have ECOG performance status 0-1. 4)? Have previously received palliative 1st line platinum based chemotherapy. (2nd or more line, prior immune checkpoint inhibitor experienced patients were allowed.) 5)? Measurable lesion by RECIST1.1 6)? HER2 IHC 3+ (2+ patients can not be enrolled) *HER2 definition http://ascopubs.org/doi/full/10.1200/JCO.2013.50.9984 7)? Have adequate major organ functions as demonstrated by the following blood counts at the time of screening: - Adequate bone marrow function as defined by absolute neutrophil count (ANC) = 1,000 /mm3, platelet count = 75,000 /mm3 and hemoglobin = 9 g/dL. - Adequate renal function, with serum creatinine = 1.5 x upper limit of normal (ULN). - Adequate hepatic function with serum total bilirubin = 1.5 x ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5 x ULN. ? Baseline LVEF >50%. 8)? Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 2 weeks prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 9)? Female subjects of childbearing potential must be willing to use an adequate method of contraception. ? Male subjects of childbearing potential must agree to use an adequate method of contraception. 10)? Be willing and able to provide written informed consent for the trial
Exclusion criteria
Exclusion criteria: 1)? Has received prior therapy with anti HER2 therapy or paclitaxel 2)? Has a history of myocardial infarction within 6 months prior to the first dose of study treatment, and other clinically significant heart disease. (e.g., unstable angina, congestive heart failure or uncontrolled hypertension). 3)? Has a known additional malignancy that progressed or required active treatment within 5 years except curatively treated non-melanoma skin cancer or carcinoma in situ (e.g., of cervix, breast, prostate). 4,5)? Has received prior anti-cancer mAb, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment or who has not recovered from adverse events to grade =2 due to previously administered treatments. 6)? Has an active infection requiring systemic antibiotics therapy. 7)? Has a history of severe hypersensitivity to antibody products. 8)? Has undergone major surgery other than diagnostic surgery (e.g., surgery done to obtain a biopsy for diagnosis without removal of an organ) within 4 weeks prior to the first dose of study treatment. 9) females who are pregnant or breastfeeding 10)? Has medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance. 11)? Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Progression-free survival | — |
Countries
Korea, Republic of
Contacts
Public Contactbhum Keam
Seoul National University Hospital
Outcome results
None listed