Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC (FOLF(HA)iri)

April 28, 2015 updated by: Alchemia Oncology

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Southern Medical Day Care Centre
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3011
        • Western General Hospital
      • Melbourne, Victoria, Australia, 3165
        • Monash Medical Centre
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: Approximately 20 months
Approximately 20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: After initial 20 patients receive 2 cycles, then 6 monthly thereafter.
Diarrhea and haematology
After initial 20 patients receive 2 cycles, then 6 monthly thereafter.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alchemia Oncology

Investigators

  • Principal Investigator: Peter Gibbs, MD, Melbourne Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

February 4, 2011

First Posted (Estimate)

February 7, 2011

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACO-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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