Metastatic Colorectal Cancer
Conditions
Keywords
mCRC, CRC, colorectal, irinotecan, Hyaluronic acid, Hyaluronan
Brief summary
Trial design: * Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with Hyaluronic acid-Irinotecan or HA-Irinotecan) regimen. * Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve. * Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom). * Dosing regimen: * Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients \> 75 years of age, the irinotecan and HA-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-fluorouracil (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 2 weeks for 8 months. * Patient accrual over approximately 12-14 months. * Monitoring to 18 months post-randomization. * 390 patients. * Progression Free Survival (PFS) primary endpoint. * Safety analysis on the initial 20 patients.
Interventions
DRUGIrintoecan
* 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.
DRUGHA-Irinotecan solution for Infusion
* 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.
Sponsors
Alchemia Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | Approximately 20 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | After initial 20 patients receive 2 cycles, then 6 monthly thereafter. | Diarrhea and haematology |
Countries
Australia
Outcome results
None listed