Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma
Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma
1. Study outline This is a multicenter, single-arm, phase II trial to evaluate the efficacy
 and safety of nanoxel plus herzuma combination chemotherapy in patients with metastatic
 salivary ductal cancer. Approximately 41 patients will be enrolled. Treatment will be
 continued until disease progression or unacceptable toxicities. Response evaluation will
 be performed every 2 cycles.

 2. Dosing & Treatment schedule D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma
 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV
 over 30mins (since 2 cycle) repeated every 3 weeks (In case of discontinuation of
 nanoxel without progression, single agent herzuma can be administered until progression)
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

 -  stage IV or recurrent cancer

 -  age ≥ 20 years

 -  ECOG performance status 0-2

 -  At least one measurable tumor lesion according to RECIST 1.1

 -  Expected survival for approximately 12 weeks or longer

 -  No prior systemic chemotherapy

 -  At least 4 weeks later after surgery or radiotherapy

 -  Written informed consent

 Exclusion Criteria:

 -  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

 -  Pregnant and nursing women (women of reproductive potential have to agree to use an
 effective contraceptive method)

 -  Current, known CNS malignancy (history of completely resected or irradiated brain
 metastases by WBRT or stereotactic radiosurgery allowed)

 -  Patients with alcohol abuse