Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma

Combination of Nanoxel and Herzuma as First-line Chemotherapy in Patients With Metastatic Salivary Duct Carcinoma : Open Label Single Arm Multicenter Phase II Study

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Salivary Duct Carcinoma
• Intervention / Treatment: Drug: nanoxel; Drug: herzuma

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: nanoxel and 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

Drug: 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; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	according to RECIST version 1.1	about 24months

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Myung-Ju Ahn, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma; Carcinoma, Ductal
• Other Study ID Numbers: 2017-11-082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No