A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)
Gemcitabine (G) given until progressive disease (PD) is still standard therapy in patients
with advanced pancreatic cancer. No standard secondline regimen is available after PD. Best
supportive care (BSC) is the main option for these patients. Our phase II study (Pelzer et
al, ASCO 2002) showed activity of the OFF (Oxaliplatin/Folinic Acid/5-FU) regimen. To
confirm these data we started this multicenter phase III study to examine OFF vs. BSC alone.
165 patients were needed for this study. Following CT/ MRT confirmed PD patients were
randomized. Stratification included duration of firstline therapy, Karnofsky Performance
Status (KPS) and tumor stage. OFF (outpatient regimen): 5-FU 2g/m² (24h)/FA 200 mg/m²
(30min) on d1, d8, d15, d22, additional Oxaliplatin 85mg/m² (2h) on day 8 and 22. Rest on
day 23 and 42.
Helmut Oettle, PD
CONKO Study Group
Germany: Ethics Commission