A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer
- Compare the 1-year survival rate of patients with locally advanced or metastatic
pancreatic cancer treated with gemcitabine with or without capecitabine.
- Compare the median and 2-year survival rates and the objective response rates of
patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is an randomized, open-label, multicenter study. Patients are stratified
according to disease stage (locally advanced vs metastatic) and performance status (0 and 1
vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral
capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 6 courses in
the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36,
and 43 during the first course. After a 1-week rest period, patients receive
gemcitabine IV over 30 minutes on days 1, 8, and 15. Subsequent courses repeat every 28
days for 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 3 months for 1 year, and then annually
Patients are followed every 3 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Survival at 1 year
Cancer Research UK
United States: Federal Government