Phase II trial of capecitabine (CAP) and oxaliplatin (OX) in patients (pts) with adeno- and undifferentiated carcinoma of unknown primary (CUP)

15594 Background: For pts. with CUP treatment options are limited and no standard first-line regimen has been identified. CAP and OX proved efficacy and tolerability in colorectal cancer and in other gastrointestinal cancer types. Monotherapy with at least one of the drugs demonstrated antineoplastic activity in cancer of the upper intestinum (pancreatic, cholangiocellular and hepatocellular carcinoma), breast cancer and NSCLC. Methods: This multicenter phase II trial was designed to investigate CAPOX in pts. with CUP. The primary end point was the overall response rate (ORR), the hypothesis an ORR (incl. 95% CI) ≥ 20%. Pts. received CAP (2000 mg/m2 d1–14) and OX (130 mg/m2 d1, q21d) at a maximum of 6 cycles. Main eligibility criteria were pts. with a non-resectable, histologically/cytologically proven adeno- or undifferentiated CUP, ECOG PS 0–2, no prior chemotherapy, absence of brain metastases. Results: 51 pts. (35 male and 16 female) were enrolled. Median age was 65, ECOG PS 0/1/2 21/20/5 pts. Predomi...