Randomized Double-blind Phase III Trial of FOLF(HA)Iri vs FOLFIRI for Second or Third Line Therapy in Irinotecan-naïve Patients With Metastatic Colorectal Cancer
- Metastatic colorectal cancer with disease progression after first or second line
- Irinotecan naïve.
- ECOG performance status of 0 or 1.
- Measurable disease, i.e. at least one measurable metastatic lesion (spiral CT or
- 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
- 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.
- 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
- Significant cardiac disease.
- Untreated or symptomatic brain or central nervous system (CNS).
- Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or
- 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