Status:
COMPLETED
Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy
Lead Sponsor:
Yonsei University
Conditions:
HER2 Positive Advanced/Metastatic/Nonresectable Biliary Tract Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 tra...
Detailed Description
This phase II study is designed to see whether trastuzumab-pkrb+FOLFOX is active as 2nd or 3rd line treatment for HER2-positive biliary tract cancer patients.
Eligibility Criteria
Inclusion
- Histologically documented recurred/metastatic/unresectable biliary tract cancer, including gallbladder cancer, intrahepatic, extrahepatic cholangiocarcinoma, or ampulla of vater cancer.
- Histologically confirmed HER2 positive biliary tract cancer. HER2-positive tumor was defined as either IHC 3+ or IHC 2+ in combination with ISH +, or ERBB2 amplification (≥6 copies) by tumor tissue NGS.
- Recurred/metastatic/unresectable biliary tract cancer patient whose disease progression was confirmed by imaging modality after gemcitabine+cisplatin containing 1st line palliative chemotherapy regimen. Previous lines should be one or two (immunotherapy monotherapy not counted).
- be willing and able to provide written informed consent/assent for the trial
- be at least 19 years of age on day of signing informed consent
- have measurable disease based on RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1
- have a performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) Performance Scale
- demonstrate adequate organ function
- No severe valvular or arrhythmic cardiac disease with LVEF ≥ 50%
- female subject of childbearing potential should have a negative urine or serum pregnancy or be willing to use birth control
Exclusion
- Previous treatment history of oxaliplatin containing chemotherapy, anti-HER2 targeting treatment (trastuzumab, neratinib, lapatinib, and etc)
- has had a prior anti-cancer chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered.
- has a known additional malignancy that is progressing or requires active treatment within 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin and thyroid cancer that has undergone potentially curative therapy or in situ cervical cancer
- has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- has known history or evidence of any disease, treatment, or laboratory results that would inhibit the patient's participation to the study.
- Has clinically significant cardiac disease, including congestive heart failure ≥ NYHA grade 2, uncontrolled hypertension, QTcF \> 470 msec or QT prolong syndrome, recent myocardiac infarction or unstable angina history
- has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
- has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- has known active Hepatitis B (HBsAg reactive and HBV DNA 100 ≥copies/ml) or Hepatitis C (anti-HCV reactive and HCV RNA \[qualitative\] is detected)
- has received a live vaccine within 30 days of planned start of study therapy.
- has an active infection requiring systemic therapy
- has history of severe adverse event or allergic reaction to 5-FU, leucovorin, oxaliplatin or trastuzumab
- need O2 supply or show dyspnea on rest due to advanced malignancy
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04722133
Start Date
June 23 2020
End Date
June 14 2023
Last Update
October 11 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine
Seoul, South Korea