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Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03614364
Recruitment Status : Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Myung-Ju Ahn, 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)

Condition or disease Intervention/treatment Phase
Salivary Duct Carcinoma Drug: nanoxel Drug: herzuma Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

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




Primary Outcome Measures :
  1. Response rate [ Time Frame: about 24months ]
    according to RECIST version 1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614364


Contacts
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Contact: Myung-Ju Ahn, PhD 82-2-3410-3438 silk.ahn@samsung.com

Locations
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Korea, Republic of
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Myung-Ju Ahn, PhD Samsung Medical Center

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Responsible Party: Myung-Ju Ahn, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03614364    
Other Study ID Numbers: 2017-11-082
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary