1 (edited by marions Tue, 30 Oct 2007 20:23:43)

Topic: Phase II Study of Gemcitabine and Capecitabine

I wanted to pass on this Single-Institution Prospective Study
Note: Only 12 patients were in this study
Advanced stage of disease not specified

A Phase II Study of Gemcitabine and Capecitabine in Advanced Cholangiocarcinoma and Carcinoma of the Gallbladder: A Single-Institution Prospective Study

2 Department of Surgical Oncology, Roswell Park Cancer Institute, Buffalo, NY, USA
3 American Cancer Society, Atlanta, GA, USA
4 Department of Biostatistics, Roswell Park Cancer Institute, Buffalo, NY, USA
5 Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263, USA

Determine the clinical benefit response (CBR), time to tumor progression (TTP), overall survival, and effect on quality of life (QOL) of gemcitabine and capecitabine in patients with advanced biliary cancer.

Methods: Gemcitabine (1000 mg/m2 IV over 30 minutes on days 1 and 8) and capecitabine (650 mg/m2 orally twice daily for 14 days) were administered and repeated every 21 days. All patients completed the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and Pancreatic Cancer Module (EORTC QLQ-C30-PAN 26) questionnaire on day 1 of each cycle. Cumulative QOL scores were calculated. The two-stage design required 17 patients to evaluate the confirmed response at nine weeks.

Results: Twelve patients with a median age of 54 years were enrolled. A median of eight cycles per patient were completed. With a median follow-up of 18.2 months, the CBR (two partial response and five stable disease) was 58% [95% confidence interval (CI) 28

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