Description:
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)
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
2017-11-082
- NCT ID:
NCT03614364
Conditions
Interventions
Drug | Synonyms | Arms |
---|
nanoxel | | nanoxel and herzuma |
herzuma | | nanoxel and herzuma |
Purpose
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)
Trial Arms
Name | Type | Description | Interventions |
---|
nanoxel and herzuma | Experimental | 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 | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Response rate |
Time Frame: | about 24months |
Safety Issue: | |
Description: | according to RECIST version 1.1 |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Samsung Medical Center |
Last Updated
August 10, 2021