Phase II Trial of Weekly 24-Hour Infusion of Gemcitabine in Patients with Advanced Gallbladder and Biliary Tract Carcinoma

Aims:

Patients with advanced gallbladder and biliary tract carcinoma face a dismal prognosis, as no effective palliative chemotherapy exists. The antitumor effect of gemcitabine is schedule-dependent rather than dose-dependent. We evaluated the activity of a prolonged infusion of gemcitabine in advanced gallbladder and biliary tract carcinomas.

Methods:

Nineteen consecutive eligible patients were enrolled. All patients were required to have histologically confirmed diagnosis and measurable disease. Gemcitabine was infused over 24 hours at a dose of 100mg/m² on days 1, 8, and 15. Treatment was repeated every 28 days until progression of disease or limiting toxicity. Tumor response was evaluated every second course by CT scans.

Results:

Eighteen patients were evaluable for response. A total of 89 cycles of therapy were administered. One partial response was observed (6%; 95% confidence interval (CI): 0–27%) and ten additional patients had stable disease for at least two months (disease control rate 61%; 95% CI: 36–83%). The therapy was well tolerated, with moderate myelosuppression as the main toxicity. The median progression free survival and median overall survival were 3.6 months (95% CI 2.6–4.6 months) and 7.5 months (95% CI 6.5–8.5 months), respectively.

Conclusions:

Weekly 24-hour gemcitabine at a dose of 100mg/m² is well tolerated. The objective response rate of this regimen in gallbladder and biliary tract carcinomas was limited. However, there was a relatively high rate of disease control for a median duration of 5.3 months (range 2.8–18.8 months).

Keywords: Gemcitabine; 24-Hour Infusion; Prolonged Infusion; Biliary Tract Neoplasms; Gallbladder Neoplasms; Cholangiocarcinoma; Chemotherapy.