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Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas.

Abstract：

OBJECTIVES:The aim of this phase II study was to evaluate the response rate to gemcitabine combined with cisplatin in patients with locally advanced, metastatic or recurrent biliary tract cancer who had received no prior chemotherapy. METHODS:The treatment consisted of cisplatin 70 mg/m(2) in intravenous infusion followed by gemcitabine 1,250 mg/m(2) in 30-min intravenous infusion on days 1 and 8, repeated every 3 weeks until disease progression, unacceptable toxicity, patient's refusal or up to 8 cycles. RESULTS:Thirty-nine patients with advanced biliary cancer were enrolled between March 2003 and August 2003. Fourteen patients (40%) had gall bladder cancer and 20 patients (57%) had cholangiocarcinoma. Thirty-two patients (91%) had metastatic disease at study entry with liver being the most commonly involved site of metastasis. About 84.5 and 94.2% of the initially planned dose were administered for gemcitabine and cisplatin, respectively. In the ITT population (n = 35), six partial responses were observed for an objective response rate of 17.1% (95% CI; 4.7-29.6%). Ten patients (28.6%) had stable disease, 16 (45.7%) progressed, and three (8.6%) were not evaluable. For the 35 patients in the ITT population, the median overall survival time was 8.6 months (95% CI; 6.1-10.4 months). The median time to disease progression was 3.2 months (95% CI; 2.3-4.9 months) and the median time to treatment failure was 3.1 months (95% CI; 1.9-4.1 months). Among the six tumor responders, the median duration of tumor response was 7.3 months (95% CI; 5.6-11.0 months). The most common grade 3/4 maximum toxicities were nausea (3.4%) and vomiting (2.7%). CONCLUSION:The combination chemotherapy with gemcitabine and cisplatin in this trial demonstrated moderate antitumor activity with favorable toxicity profile.

journal_name

Cancer Chemother Pharmacol

journal_title

Cancer chemotherapy and pharmacology

authors

Lee J,Kim TY,Lee MA,Ahn MJ,Kim HK,Lim HY,Lee NS,Park BJ,Kim JS,Korean Cancer Study Group.

doi

10.1007/s00280-007-0444-5

subject

Has Abstract

pub_date

2008-01-01 00:00:00

pages

47-52

issue

eissn

0344-5704

issn

1432-0843

journal_volume

pub_type

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Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas.