Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC
This trial is active, not recruiting.
|Condition||metastatic colorectal cancer|
|Treatments||irintoecan, ha-irinotecan solution for infusion|
|Start date||December 2011|
|End date||October 2014|
|Trial size||390 participants|
|Trial identifier||NCT01290783, ACO-002|
- 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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Wollongong, Australia||Southern Medical Day Care Centre||no longer recruiting|
|Melbourne, Australia||Monash Medical Centre||no longer recruiting|
|Melbourne, Australia||Royal Melbourne Hospital||no longer recruiting|
|Melbourne, Australia||Western General Hospital||no longer recruiting|
|Wodonga, Australia||Border Medical Oncology||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Progression Free Survival (PFS)
time frame: Approximately 20 months
time frame: After initial 20 patients receive 2 cycles, then 6 monthly thereafter.
Male or female participants at least 18 years old.
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.
|Official title||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|
|Principal investigator||Peter Gibbs, MD|
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