Inclusion Criteria

Inclusion criteria:

- Histologically confirmed colorectal cancer: unresectable local recurrence or distant
metastases;

- Measurable disease (RECIST criteria);

- Refractory to 5-FU / leucovorin and irinotecan as described below;

- No prior therapy with oxaliplatin, any other platinum or capecitabine;

- ECOG score 0-2 (Karnofsky 100-70%);

- Life expectancy of greater then or equal to 5 months;

- Adequate hematopoietic, liver and renal function;

- Women of child-bearing potential have to practice adequate contraception;

- Signed written informed consent;

- Subjects must be willing to be followed during the course of treatment/observation
and follow-up.

Refractory metastatic colorectal cancer

The following subjects are regarded refractory to treatment:

- Those with progression while receiving 5-FU/LV/irinotecan;

- Those with progression on irinotecan after prior 5-FU/LV treatment;

- Progression within six months of adjuvant 5-FU/LV/irinotecan;

- Progression within six months of adjuvant 5-FU/LV followed by progression on
irinotecan

Subjects must have received at least one or more commonly used 5-FU/leucovorin and
irinotecan regimens. Prior adjuvant therapy is allowed including 5-FU/leucovorin or other
fluoropyrimidines except capecitabine and irinotecan.

Exclusion criteria:

- Previously diagnosed brain metastases if symptomatic and requiring active therapy;

- Other cancers within the last five years, with the exception of adequately treated
cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell
carcinoma of the skin;

- Concurrent chemotherapy or immunotherapy;

- Prior therapy for colorectal cancer within one month of admission to the present
study;

- Primary or secondary immunodeficiency or use of corticosteroids or other
immunosuppressive medication;

- Any serious concomitant medical or mental illness requiring intense therapy and
interfering with participation in this study;

- Women must not be pregnant or breast-feeding;

- No participation in any clinical trial involving investigational drugs within 1 month
from enrollment into the present study.