A phase II study of gemcitabine in combination with oxaliplatin as first-line chemotherapy in patients with inoperable biliary tract cancer.
OBJECTIVE
The aim of this study is to investigate the efficacy and safety of gemcitabine and oxaliplatin combination chemotherapy as first-line therapy in patients with inoperable biliary tract cancer (BTC).


METHODS
The treatment of this non-randomized phase II study consisted of gemcitabine 1,000 mg/m(2) intravenously (i.v.) on day 1 and oxaliplatin 85 mg/m(2) i.v. on day 2 every 2 weeks until disease progression, unaccep toxicity or patients' refusal.


RESULTS
From Sept 2006 to Oct 2007, 40 patients were enrolled. In the ITT analysis, the objective response rate was 15.0% and the disease control rate was 52.5%. The median overall survival (95% CI) was 8.5 months (6.4-10.7) and the time to progression was 4.2 months (0.5-7.9). For the 305 cycles, observed grade 3/4 toxicity was uncommon.


CONCLUSIONS
Gemcitabine and dose adjusted oxaliplatin combination chemotherapy had moderate anti-tumor activity and was well tolerated as a first-line treatment for patients with inoperable BTC.
Kim
Hyun Jung
HJ
Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon Hospital, 1174, Jung-Dong, Wonmi-Gu, Bucheon-Si, Gyeonggi-Do, 420-853, South Korea.
Lee
Nam Su
NS
Lee
Sang-Cheol
SC
Bae
Sang Byung
SB
Kim
Chan Kyu
CK
Cheon
Young Gook
YG
Kim
Young Seok
YS
Moon
Jong Ho
JH
Cho
Young Deok
YD
Park
Sang Heum
SH
Lee
Kyu Taek
KT
Park
Sung Kyu
SK
Won
Jong-Ho
JH
Park
Hee Sook
HS
Hong
Dae Sik
DS
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000556:secondary; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine