Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer

Inclusion Criteria: * Histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-FU/FA * At least one measurable lesion according to RECIST criteria for both Phase I and II * ECOG performance status 0 or 1 * Adequate hematologic, renal and hepatic function * Wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy Exclusion Criteria: * Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix. * Pregnant or lactating patients * Prior treatment with camptothecins * Presence or history of CNS metastasis or carcinomatous leptomeningitis * Current active infection per investigator assessment * Unresolved bowel obstruction or partial obstruction, uncontrolled Crohn's disease or ulcerative colitis * Current history of chronic diarrhea greater than or equal to grade 1 (CTCAE version 3)