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Trastuzumab in HER2-positive Biliary Tract Cancer (BILHER)

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ClinicalTrials.gov Identifier: NCT03613168
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Changhoon Yoo, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Biliary Tract Cancer HER-2 Protein Overexpression HER-2 Gene Amplification Drug: Trastuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pilot Study of Trastuzumab in Combination With Gemcitabine Plus Cisplatin for HER2-positive Biliary Tract Cancer
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
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
Drug: Trastuzumab
Trastuzumab plus gemcitabine/cisplatin




Primary Outcome Measures :
  1. Response rate [ Time Frame: 6 months ]
    Best response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  2. Adverse events [ Time Frame: 2 years ]
    Adverse events graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
    Time between the initiation of chemotherapy and disease progression or death

  2. Overall survival [ Time Frame: 2 years ]
    Time between the initiation of chemotherapy and any cause of death



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03613168


Contacts
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Contact: Changhoon Yoo, MD +82230101727 yooc@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Changhoon Yoo, MD         
Principal Investigator: Changhoon Yoo, MD         
Sponsors and Collaborators
Changhoon Yoo
Investigators
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Principal Investigator: Changhoon Yoo, MD Asan Medical Center

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Responsible Party: Changhoon Yoo, Assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03613168     History of Changes
Other Study ID Numbers: BTC-HER2
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Changhoon Yoo, Asan Medical Center:
Cholangiocarcinoma
Biliary Tract Cancer
Trastuzumab
Additional relevant MeSH terms:
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Cholangiocarcinoma
Biliary Tract Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Cisplatin
Trastuzumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological