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.