Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC (FOLF(HA)iri)
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ClinicalTrials.gov Identifier: NCT01290783
Recruitment Status : Unknown
Verified August 2014 by Alchemia Oncology. Recruitment status was: Active, not recruiting
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Metastatic colorectal cancer with disease progression after first or second line chemotherapy
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.
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.