A Phase III Study of Gemcitabine Plus Capecitabine (GEMCAP) Versus Gemcitabine Alone in Advanced Biliary Cancer
- To compare overall survival (OS) rates in patients with locally advanced, unresectable
or metastatic biliary tree cancer treated with combined gemcitabine hydrochloride and
capecitabine vs. gemcitabine hydrochloride alone.
- To compare progression-free survival (PFS) in this patient group.
- To compare response rates (complete response [CR] and partial response [PR]) in this
- To compare stable disease (SD) rates in this patient group.
- To compare rate of disease control (CR, PR and SD) in this patient group.
- To estimate and compare response duration in this patient group.
- To compare the effects of these treatments on measures of quality of life in this
patient group using the EORTC QLQ-C30.
- To compare the nature, severity and frequency of toxicities between the two arms.
OUTLINE: This is a multicenter study. Patients are stratified according to tumour type
(cholangiocarcinoma vs. gallbladder or biliary unknown), ECOG performance status (0-1 vs.
2), extent of disease (locally advanced vs. metastatic), and treatment center. Patients are
randomized to 1 of 2 treatment arms.
- Arm I (Gemcitabine hydrochloride and capecitabine): Patients receive gemcitabine
hydrochloride IV on days 1 and 8 and oral capecitabine twice daily on days 1-14.
Treatment repeats every 21 days in the absence of disease progression or unacceptable
- Arm II (Gemcitabine hydrochloride alone): Patients receive gemcitabine hydrochloride IV
on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at 12 weeks after randomization and 4 weeks after completion of
After completion of study treatment, patients are followed at 4 weeks and then every 12
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Jennifer Knox, MD
Princess Margaret Hospital, Canada
United States: Federal Government