Oxaliplatin/folinic acid/5-fluorouracil [24h] (OFF) plus best supportive care versus best supportive care alone (BSC) in second-line therapy of gemcitabine-refractory advanced pancreatic cancer (CONKO 003)

4031 Objective: Gemcitabine (G) is standard first line therapy in advanced pancreatic cancer. After disease progression no standard regime is available. Our phase II study (Pelzer et al; ASCO 2002; A: 684) showed activity of the OFF regimen in 23 patients (pts). To confirm these data we started a multicenter phase III study to determine the efficiency, toxicity and quality of life of OFF vs. BSC. After 46 pts. out of 165 planned pts. the BSC arm had to be closed because BSC alone was not longer accepted by participating centers. Methods: Following confirmed failure with G in 1st line we randomized pts. to BSC with OFF (A) or BSC (B) alone. Stratification included duration of 1st line therapy, Karnofsky Performance Status (KPS) and tumor stage. OFF as outpatient regimen: FU 2g/m2 (24h)/FA 200 mg/m2 (30min) on d1, d8, d15, d22 in combination with Oxaliplatin 85mg/m2 (2h) on day 8 and 22. Therapy paused on days 23 to 42. Eligibility criteria were KPS>60%, adequate hematological, renal and liver functions. Re...