Phase II trial of gemcitabine (G), oxaliplatin (O), and erlotinib (T) for the treatment of hepatocellular carcinoma (HCC) and biliary tree cancers (BTC).

4153 Background: HCC is increasing in the USA; BTC, less common in the USA, is not rare in New Mexico. G-O is active in HCC and BTC. Both express EGFR. T, a TKI has activity against BTC and HCC. Therefore, this Western IRB-approved phase II trial of G- O+T in HCC and BTC was launched. Methods: Eligibility: Histologic confirmation and CT/MRI (C/M) measurable HCC. In hepatitis/alcoholic cirrhosis, AFP of ≥ 400 ng/mL and a typical C/M of HCC sufficed. A platelet (Plt) count of ≥ 100,000, Child-Pugh (C-P) class ≤ B cirrhosis, adequate renal function, and ECOG PS of ≤ 2 were required. BTC pts required measurable and histologically confirmed disease, and a decreasing bilirubin of ≤ 3.5 mg/dL post decompression of biliary obstruction and adequate bone marrow, renal, and hepatic reserve. Simon's 2 stage optimal phase II trial design was used. A disease-control rare (DCR), (CR+PR+ SD) at 24 weeks of ≤ 20% and > 40% (P0 and P1 of 0.2 and 0.4 respectively ) were set as undesirable (null) and desirable results. Treat...