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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
First Posted : February 7, 2011
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Alchemia Oncology

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Irintoecan Drug: HA-Irinotecan solution for Infusion Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2011
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FOLFIRI Drug: Irintoecan
  • 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: HA-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.




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Approximately 20 months ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: After initial 20 patients receive 2 cycles, then 6 monthly thereafter. ]
    Diarrhea and haematology



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290783


Locations
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Australia, New South Wales
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia, 2500
Australia, Victoria
Western General Hospital
Melbourne, Victoria, Australia, 3011
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Monash Medical Centre
Melbourne, Victoria, Australia, 3165
Border Medical Oncology
Wodonga, Victoria, Australia, 3690
Sponsors and Collaborators
Alchemia Oncology
Investigators
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Principal Investigator: Peter Gibbs, MD Melbourne Health

Publications:
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Responsible Party: Alchemia Oncology
ClinicalTrials.gov Identifier: NCT01290783     History of Changes
Other Study ID Numbers: ACO-002
First Posted: February 7, 2011    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: August 2014

Keywords provided by Alchemia Oncology:
mCRC
CRC
colorectal
irinotecan
Hyaluronic acid
Hyaluronan

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents