Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma

Phase 2

• Conditions: Salivary Duct Carcinoma
• Interventions: Drug: nanoxel; Drug: herzuma

• Registration Number: NCT03614364
• Lead Sponsor: Samsung Medical Center

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Study Start: 2018-09-20
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Last Update Posted: 2022-01-04
• Primary Completion: 2022-09
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• 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
• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nanoxel and herzuma	nanoxel	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
nanoxel and herzuma	herzuma	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

Primary Outcome Measures

Name	Time	Method
Response rate	about 24months	according to RECIST version 1.1

Trial Locations

Locations (1)

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of