Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma
Primary Purpose
Salivary Duct Carcinoma
Status
Active
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
nanoxel
herzuma
Sponsored by
About this trial
This is an interventional treatment trial for Salivary Duct Carcinoma
Eligibility Criteria
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
Sites / Locations
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nanoxel and herzuma
Arm Description
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
Outcomes
Primary Outcome Measures
Response rate
according to RECIST version 1.1
Secondary Outcome Measures
Full Information
NCT ID
NCT03614364
First Posted
July 30, 2018
Last Updated
December 30, 2021
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03614364
Brief Title
Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma
Official Title
Combination of Nanoxel and Herzuma as First-line Chemotherapy in Patients With Metastatic Salivary Duct Carcinoma : Open Label Single Arm Multicenter Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salivary Duct Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nanoxel and herzuma
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
nanoxel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
herzuma
Intervention Description
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 Measure Information:
Title
Response rate
Description
according to RECIST version 1.1
Time Frame
about 24months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung-Ju Ahn, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma
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