Trastuzumab in HER2-positive Biliary Tract Cancer

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

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Response rate

Secondary Outcome

 Progression-free survival

Condition

Cholangiocarcinoma

Intervention

Trastuzumab

Study Arms / Comparison Groups

 Trastuzumab plus Gem/Cis

Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

4

Start Date

June 1, 2019

Completion Date

January 4, 2021

Primary Completion Date

November 1, 2020

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
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Changhoon Yoo, MD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

NCT ID

NCT03613168

Organization ID

BTC-HER2

Responsible Party

Sponsor-Investigator

Study Sponsor

Changhoon Yoo

Study Sponsor

Changhoon Yoo, MD, Principal Investigator, Asan Medical Center

Verification Date

January 2021