Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression
- Compare the overall survival of patients with unresectable metastatic pancreatic cancer
treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine
hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin
calcium, and cisplatin.
- Compare progression-free survival 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.
- Compare the percentage of these patients needing second-line therapy.
- Compare the duration of hospitalization of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG
performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar
region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100
minutes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over
1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment
repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or
100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on
days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression
or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for
7 weeks in the absence of disease progression or unacceptable toxicity. Patients with
disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm
Quality of life is assessed at baseline and then every 2 months.
After completion of study therapy, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Jean-Francois Seitz, MD
CHU de la Timone
United States: Federal Government