Combination chomotherapy of nanoxel and herzuma in patients with relapsed or metastatic salivary gland carcinoma : open label single arm multicenter phase II study

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0003545
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

?Histologically-confirmed HER2 positive (immunohistochemistry [IHC] 3+, and/or fluorescence in situ hybridization[FISH] positive with = two-fold amplification) salivary duct carcinoma(SDC), and other salivary gland carcinomas which are similar to SDC in histopathological findings, including adenocarcinoma, not otherwise specified, acinic cell carcinoma, squamous cell carcinoma, anaplastic carcinoma, high grade mucoepidermoid carcinoma, and carcinoma ex pleomorphic adenoma (Except for Adenoid cystic carcinoma)
? locally advanced, unresectable, relapse or metastatic cancer
? Allow treatment of all previous orders
? age = 20 years
? ECOG performance status 0-1
? At least one measurable tumor lesion according to RECIST 1.1
? Expected survival for approximately 12 weeks or longerExpected survival for approximately 12 weeks or longer
? At least 4 weeks later after surgery or at least 2 weeks after radiotherapy
? Organ function as evidence by the following;,
ANC = 1,500 cells/mm3,
Hemoglobin = 10 g/dL (transfusion allowed),
Platelet count = 100,000 /mm3;
Total bilirubin = 1.5 × ULN, AST/ALT = 2.5 × ULN, (if liver metastases(+): AST, ALT =5.0 x ULN);
Creatinine clearance = 50 mL/min or serum creatinine = 1.5 x UNL
? Echocardiography showed normal LVEF =55%)
? Written informed consent

Exclusion Criteria

? Those who have received Her-2 treatment (ex: Herceptin etc.)
? Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months(congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
? Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection, infectious fever
? Patients with active hepatitis B, active hepatitis C, HIV
? Pregnant and nursing women (Women of childbearing age should agree to use effective contraceptive methods from the first day of the study drug infusion to 7 months after the last dose of the study drug infusion, and agree to check for pregnancy test(result: negative)).
? Male patients, those who did not consent to not donate sperm from the first day of the study drug infusion to 90 days after the last dose of study drug infusion
? Within the past 5 years, a malignant tumor of the other site (except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.)
? Patients with meningiomas, active metastatic lesions under the brain or subdural (Exceptions are made when completing topical treatment (radiotherapy, stereotactic surgery) and using stable doses of anticonvulsants and steroids before starting clinical trial treatment).
? Patients who were treated with anticancer treatments, radiotherapy, chemotherapy, clinical trial medication within 2 weeks before starting clinical trial
? Toxicity above CTCAE grade 2, not resolved from previous chemotherapy (Except: hair loss, vitiligo)
? Patient with history of rodent-derived protein, trastuzumab or hypersensitivity to the components of trastuzumab
? Patient with severe respiratory distress due to progressive malignant tumors or who need oxygen supplementation
? Patient with severe bone marrow suppression
? Patient with Nanoxel and components of Nanoxel, severe hypersensitivity reactions to polysorbate 80
? Patient with history of exposure to the following anthracycline cumulative doses
- Doxorubicin > 500mg/m2
- Liposomal doxorubicin > 500mg/m2
- Epirubicin > 720mg/m2
- Mitoxantrone > 120mg/m2
- Idarubicin > 90mg/m2
(If another anthracycline or two or more anthracyclines are used, the cumulative dose should not exceed 500mg/m2 doxorubicin equivalent capacity.)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response rate

Secondary Outcome Measures

Name	Time	Method
overall survival, progression-free survival, safety and toxicity, exploratory biomarker analysis