Randomized phase 2, first line, of 5-FU, folinic acid, gemcitabine (FFG) versus FOLFOX-4 in patients (pts) with metastatic colorectal carcinoma (mCRC). Work in progress

3704 Background: FOLFOX-4 recently emerged as standard chemotherapy for mCRC. Over the last 4 years we have been reporting encouraging results with FFG and thus began a randomized trial of FFG v. FOLFOX (2005 ASCO/GI poster). Bevacizumab was added to both arms since. Methods: Fifty four out of 190 planned pts are evaluable now. Interim analysis will be after enrollment of 90 pts. Median age is 64, PS 0–1 and 50% of pts have at least 3 metastatic tumors. RECIST criteria is used for the evaluation of response. Bevacizumab 5mg/kg.b.w. is given IV q. 2 weeks. FFG as described before is given weekly x 6 q. 8 weeks: Folinic Acid 100mg/m2 IV/60min., 5-FU 450mg/m2 IVP and Gemcitabine 900mg/m2 IV/90min. FOLFOX-4 is given according to standard criteria. All pts in main institution have blood and/or tumor tissue analysis for circulating tumor cells (CTC), microarrays and pharmacogenomics. Twenty ml of blood are drawn into sodium heparinized tube. A novel cell adhesion matrix (CAM) is used to detect the presence of v...