Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC
Keywords
Abstract
Dates
| Last Verified: | 07/31/2014 |
| First Submitted: | 01/30/2011 |
| Estimated Enrollment Submitted: | 02/03/2011 |
| First Posted: | 02/06/2011 |
| Last Update Submitted: | 04/27/2015 |
| Last Update Posted: | 04/28/2015 |
| Actual Study Start Date: | 11/30/2011 |
| Estimated Primary Completion Date: | 09/30/2014 |
| Estimated Study Completion Date: | 11/30/2015 |
Condition or disease
Intervention/treatment
Drug: FOLFIRI
Drug: FOLF(HA)iri
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: FOLFIRI | Drug: FOLFIRI Irinotecan, 180 mg/m2 IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2).
Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
Repeat every two weeks.
8 months of treatment. |
| Experimental: FOLF(HA)iri | Drug: FOLF(HA)iri HA-Irinotecan (irinotecan 180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2).
Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
Repeat every two weeks
8 months of treatment. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. Progression Free Survival (PFS) [Approximately 20 months]
Secondary Outcome Measures
1. Safety [After initial 20 patients receive 2 cycles, then 6 monthly thereafter.]
