Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial
- Compare the overall survival of patients with advanced pancreatic cancer treated with
gemcitabine with or without capecitabine.
- Compare the clinical benefit response, objective tumor response, duration of response,
and time to progression in 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 a randomized, multicenter study. Patients are stratified according to
metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%),
and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral
capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks in the absence
of disease progression or unacceptable toxicity.
- Arm II: Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks.
After 1 week of rest, patients receive gemcitabine IV over 30 minutes weekly for 3
weeks. Treatment then repeats every 4 weeks in the absence of disease progression or
Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each
Patients are followed every 9 weeks.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Gemcitabine + Capecitabine vs. Gemcitabine alone
To compare survival, efficacy, quality of life and toxicity between the combination therapy (Capecitabine and Gemcitabine) and the monotherapy (Gemcitabine alone) in advanced pancreatic cancer.
Richard Herrmann, MD