Multicenter Phase II Clinical Trial of Genexol-PM® with Gemcitabine in Advanced Biliary Tract Cancer.
This multicenter phase II clinical trial was designed to evaluate the efficacy and safety of weekly Genexol-PM® and gemcitabine combination chemotherapy in patients with unresectable or metastatic biliary tract cancer.



Patients received 100 mg/m2Genexol-PM® and 1,000 mg/m2gemcitabine intravenously on days 1 and 8 every 21 days.



Out of 39 patients, there were 10 partial responses (25.6%) and 18 with stable diseases (46.2%) were confirmed with median response duration 4.1 months. The median progression-free survival was 5.9±1.6 months and overall survival 11.9±1.4 months. The median number of cycles administered was 4.0 (range=1-10). Grade 3 or more neutropenia occurred in 12 patients (26.7%). The most common grade 3/4 non-hematological toxicities were febrile neutropenia (13.4%) and elevation of liver enzymes (6.7%).



Weekly Genexol-PM® combined with gemcitabine demonstrated sufficient antitumor activity to warrant further development when used as first-line chemotherapy for advanced biliary tract cancer.
Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.|Pain Research Center, School of Medicine, Keimyung University, Daegu, Republic of Korea.
Jin Young
JY
Kim
Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.
Young Rok
YR
Do
Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.
Hong Suk
HS
Song
Division of Hematology/Oncology, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Republic of Korea.
Yoon Young
YY
Cho
Division of Hematology/Oncology, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Republic of Korea.
Hun Mo
HM
Ryoo
Division of Hematology/Oncology, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Republic of Korea.
Sung Hwa
SH
Bae
Division of Hematology/Oncology, Department of Internal Medicine, Kyungpook National University Medical Center, Daegu, Republic of Korea.
Jong Gwang
JG
Kim
Division of Hematology/Oncology, Department of Internal Medicine, Kyungpook National University Medical Center, Daegu, Republic of Korea.
Yee Soo
YS
Chae
Division of Hematology/Oncology, Department of Internal Medicine, Kyungpook National University Medical Center, Daegu, Republic of Korea.
Byung Woog
BW
Kang
Division of Hematology/Oncology, Department of Internal Medicine, Ulsan University Hospital, Ulsan, Republic of Korea.
Jin Ho
JH
Baek
Division of Hematology/Oncology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Republic of Korea.
Min Kyoung
MK
Kim
Division of Hematology/Oncology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Republic of Korea.
Kyung Hee
KH
Lee
Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea keonukpark@gmail.com.
Keonuk
K
Park
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D018572:Disease-Free Survival; D064147:Febrile Neutropenia; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage*; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine
Biliary tract cancer; chemotherapy; clinical trial; gemcitabine; paclitaxel; phase II; polymeric micelle