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Trastuzumab in HER2-positive Biliary Tract Cancer (BILHER)

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ClinicalTrials.gov Identifier: NCT03613168
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Changhoon Yoo, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE July 28, 2018
First Posted Date  ICMJE August 2, 2018
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE June 1, 2019
Actual Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2018)
  • Response rate [ Time Frame: 6 months ]
    Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Adverse events [ Time Frame: 2 years ]
    Adverse events graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2018)
  • Progression-free survival [ Time Frame: 2 years ]
    Time between the initiation of chemotherapy and disease progression or death
  • Overall survival [ Time Frame: 2 years ]
    Time between the initiation of chemotherapy and any cause of death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trastuzumab in HER2-positive Biliary Tract Cancer
Official Title  ICMJE The Pilot Study of Trastuzumab in Combination With Gemcitabine Plus Cisplatin for HER2-positive Biliary Tract Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cholangiocarcinoma
  • Biliary Tract Cancer
  • HER-2 Protein Overexpression
  • HER-2 Gene Amplification
Intervention  ICMJE Drug: Trastuzumab
Trastuzumab plus gemcitabine/cisplatin
Study Arms  ICMJE Experimental: Trastuzumab plus Gem/Cis
Gemcitabine 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
Intervention: Drug: Trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2021)
4
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2018)
15
Actual Study Completion Date  ICMJE January 4, 2021
Actual Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03613168
Other Study ID Numbers  ICMJE BTC-HER2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Changhoon Yoo, Asan Medical Center
Study Sponsor  ICMJE Changhoon Yoo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Changhoon Yoo, MD Asan Medical Center
PRS Account Asan Medical Center
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP