Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
- Compare the overall survival of patients with locally advanced or metastatic
unresectable pancreatic adenocarcinoma treated with gemcitabine with or without
- Compare the time of response in patients treated with these regimens.
- Compare the clinical benefit of and tolerance to these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the progression-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally
advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and
9-11 in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV
over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence
of disease progression or unacceptable toxicity.
After the completion of chemotherapy, patients with locally advanced disease receive
Quality of life is assessed at baseline and then every 2 months.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this
study within 24 months.
Allocation: Randomized, Primary Purpose: Treatment
Christophe Louvet, MD, PhD
Hopital Saint Antoine
United States: Federal Government