A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

Inclusion Criteria: Colorectal cancer, locally recurrent, unresectable or metastatic disease (AJCC); Measurable disease (RECIST criteria); Cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan; ECOG performance score of 0-2; Adequate hematopoietic, liver and renal function; Adequate cardiac function (maximum of class II, NYHA); Women of child-bearing potential must have a negative urine or serum pregnancy test; Signed written informed consent; Subjects must be willing to to be followed during the course of treatment/observation and follow-up. Exclusion Criteria: Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer; Pregnant or breast feeding subjects, or male or female subjects of child producing potential who will not agree to use adequate contraception during the treatment phase of the study; Prior therapy with oxaliplatin; Known brain metastases; Active, uncontrolled infection or other serious medical illnesses; Subjects may not be using or have used any investigational therapy during four weeks before start of the protocol treatment.