Inclusion Criteria:

- Metastatic colorectal cancer with disease progression after first or second line
chemotherapy

- Irinotecan naïve.

- ECOG performance status of 0 or 1.

- Measurable disease, i.e. at least one measurable metastatic lesion (spiral CT or
MRI).

- Histological proof of colorectal cancer.

- 18 years of age and older.

- Adequately recovered from and at least 4 weeks after recent surgery or chemotherapy.

- Women of child-bearing potential (WOCBP) and male partners of WOCBP must agree to use
adequate contraception.

- Patient consent obtained and signed according to local and/or national ethics.

- CT or MRI scan of chest/abdomen/pelvis within 21 days prior to randomization.

- Hematology done within 14 days prior to randomization.

- Chemistry done within 14 days prior to randomization.

Exclusion Criteria:

- History of other malignancies, except adequately treated non-melanoma skin cancer,
curatively treated in-situ cancer of the cervix, or other solid tumors curatively
treated with no evidence of disease for > 5 years.

- Locally advanced or recurrent disease only.

- Unsuitability for irinotecan including known Gilbert's syndrome, active inflammatory
bowel disease or chronic diarrhea greater than or equal to grade 2.

- Abdominal or pelvic radiation therapy within the last 12 months.

- Women who are pregnant or breastfeeding.

- Any condition (e.g., psychological, geographical) that would render the protocol
treatment dangerous.

- Significant cardiac disease.

- Untreated or symptomatic brain or central nervous system (CNS).

- Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or
paracentesis.

- Current partial or complete bowel obstruction.

- Concomitant active infection.

- Enrolled in any other investigational trial, unless treatment in that trial has been
discontinued at least 30 days prior to signing the Informed Consent for the ACO-002
study.