Clinical Trials /

Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma

NCT03614364

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)

Related Conditions:
  • Malignant Salivary Gland Neoplasm
  • Salivary Carcinoma, NOS
  • Salivary Duct Carcinoma
  • Salivary Gland Acinic Cell Carcinoma
  • Salivary Gland Adenocarcinoma
  • Salivary Gland Carcinoma ex Pleomorphic Adenoma
  • Salivary Gland Mucoepidermoid Carcinoma
  • Salivary Gland Small Cell Carcinoma
  • Salivary Gland Squamous Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Salivary Duct Carcinoma

Interventions

DrugSynonymsArms
nanoxelnanoxel and herzuma
herzumananoxel 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

NameTypeDescriptionInterventions
nanoxel and herzumaExperimentalD1 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
  • herzuma

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:Not yet recruiting
Lead Sponsor:Samsung Medical Center

Last Updated