Clinical Trials /

Trastuzumab in HER2-positive Biliary Tract Cancer

NCT03613168

Description:

Trastuzumab is approved for the treatment of HER2-positive breast cancer and gastric cancer. The recent study showed that HER2 overexpression or amplification is noted about 5-15% of total biliary tract cancer patients. The aim of this study is to evaluate the efficacy and safety of trastuzumab in the combination of current standard gemcitabine plus cisplatin.

Related Conditions:
  • Bile Duct Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Trastuzumab in HER2-positive Biliary Tract Cancer
  • Official Title: The Pilot Study of Trastuzumab in Combination With Gemcitabine Plus Cisplatin for HER2-positive Biliary Tract Cancer

Clinical Trial IDs

  • ORG STUDY ID: BTC-HER2
  • NCT ID: NCT03613168

Conditions

  • Cholangiocarcinoma
  • Biliary Tract Cancer
  • HER-2 Protein Overexpression
  • HER-2 Gene Amplification

Interventions

DrugSynonymsArms
TrastuzumabTrastuzumab plus Gem/Cis

Purpose

Trastuzumab is approved for the treatment of HER2-positive breast cancer and gastric cancer. The recent study showed that HER2 overexpression or amplification is noted about 5-15% of total biliary tract cancer patients. The aim of this study is to evaluate the efficacy and safety of trastuzumab in the combination of current standard gemcitabine plus cisplatin.

Trial Arms

NameTypeDescriptionInterventions
Trastuzumab plus Gem/CisExperimentalGemcitabine 1,000 mg/m2 Day 1 and Day 8, every 3 weeks Cisplatin 25 mg/m2 Day 1 and Day 8, every 3 weeks Trastuzumab, every 3 weeks, 8 mg/kg at first cycle then, 6 mg/kg
  • Trastuzumab

Eligibility Criteria

        Inclusion Criteria:

          1. The subject with disease that is not amendable to a curative treatment approach or
             locally advanced or metastatic or unresectable CCC with histological diagnosis

          2. At least one measurable(per RECIST 1.1) lesion

          3. Primary or metastatic tumor with HER2 positive defined on IHC2+, FISH+ or IHC3+

          4. ECOG Performance status 0 or 1

          5. At least 3 months for life expectancy Common inclusion criteria

          6. Men or women over 19 years at time of signing ICF

          7. Signed Informed Consent Form

             Exclusion Criteria:

          8. Received prior chemotherapy for advanced/metastatic disease (the adjuvant/neoadjuvant
             chemotherapy completed at least 6 months before enrolled will be accepted)

          9. Not recovery from toxicities related to any prior treatments excluding alopecia (eg,
             neurological toxicity to ≥ Grade 2)

         10. History of malignancy other than CCC within 5 years prior to screening, with the
             exception of malignancies with a negligible risk of metastasis or death, such as
             carcinoma in situ or thyroid papillary carcinoma Hematology, chemistry or organ
             function

         11. ANC < 1.5 × 109/L, or Platelet < 100 × 109/L

         12. Total bilirubin > 1.5 × ULN; or AST/ ALT > 2.5 × ULN (or if the tumor has expanded
             into the liver, > 5 × ULN); or, alkaline phosphatase > 2.5 × ULN (or > 5 × if the
             tumor has expanded into the liver, or > 10 × ULN if the tumor has expanded into the
             brain without liver,); or albumin < 2.5 g/dL

         13. Creatinine clearance < 60 mL/min(calculated using the Cockcroft-Gault formula) Other
             exclusion criteria related to IP

         14. History of proved congestive heart failure; angina with medication; evidence of
             transmural myocardial infarction on ECG; uncontrolled hypertension(systolic> 180 mmHg
             or diastolic> 100 mmHg); clinically significant heart valve disease; uncontrolled
             arrhythmia

         15. LVEF < 50% (calculated by cardiac sonography or MUGA)

         16. Subject with rest dyspnea due to metastatic tumor or other disease or who needs oxygen
             therapy

         17. Chronic or high-dose corticosteroid treatment

         18. Clinically significant Hearing impairment Common exclusion criteria

         19. History or evidence of CNS metastases

         20. Interstitial pneumonia or pulmonary fibrosis with symptom and exact lesion on chest
             X-ray

         21. Hearing loss

         22. Uncontrolled significant systemic disease (eg, infection or uncontrolled DM)

         23. Pregnant or lactating females

         24. Sexually active fertile subjects without contraception

         25. Treatment with other investigational therapy within 4 weeks prior to initiation of
             study treatment

         26. Radiotherapy within 4 weeks prior to initiation of study treatment (the rest at least
             2 weeks after palliative radiotherapy for bone metastasis and recovery from the
             effects of radiation will be accepted.)

         27. Major surgery within 4 weeks prior to initiation of study treatment

         28. History of HIV and active HBV or HCV

         29. Previously identified allergy or hypersensitivity to components of the study treatment
             formulations
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response rate
Time Frame:6 months
Safety Issue:
Description:Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Secondary Outcome Measures

Measure:Progression-free survival
Time Frame:2 years
Safety Issue:
Description:Time between the initiation of chemotherapy and disease progression or death
Measure:Overall survival
Time Frame:2 years
Safety Issue:
Description:Time between the initiation of chemotherapy and any cause of death

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Changhoon Yoo

Trial Keywords

  • Cholangiocarcinoma
  • Biliary Tract Cancer
  • Trastuzumab

Last Updated