A Phase II Study of Aroplatin in Subjects With Recurrent, Unresectable and Metastatic Colorectal Cancer Refractory to 5-Fluorouracil (5-FU)/Leucovorin or Capecitabine, and Irinotecan

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.