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

Primary Purpose

Metastatic Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Irintoecan
HA-Irinotecan solution for Infusion
Sponsored by
Alchemia Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring mCRC, CRC, colorectal, irinotecan, Hyaluronic acid, Hyaluronan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southern Medical Day Care Centre
  • Western General Hospital
  • Royal Melbourne Hospital
  • Monash Medical Centre
  • Border Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FOLFIRI

FOLF(HA)iri

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Secondary Outcome Measures

Safety
Diarrhea and haematology

Full Information

First Posted
January 31, 2011
Last Updated
April 28, 2015
Sponsor
Alchemia Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT01290783
Brief Title
Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC
Acronym
FOLF(HA)iri
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alchemia Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
mCRC, CRC, colorectal, irinotecan, Hyaluronic acid, Hyaluronan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FOLFIRI
Arm Type
Active Comparator
Arm Title
FOLF(HA)iri
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Irintoecan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
HA-Irinotecan solution for Infusion
Intervention Description
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 Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
Approximately 20 months
Secondary Outcome Measure Information:
Title
Safety
Description
Diarrhea and haematology
Time Frame
After initial 20 patients receive 2 cycles, then 6 monthly thereafter.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gibbs, MD
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Western General Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Monash Medical Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
20333384
Citation
Gibbs P, Clingan PR, Ganju V, Strickland AH, Wong SS, Tebbutt NC, Underhill CR, Fox RM, Clavant SP, Leung J, Pho M, Brown TJ. Hyaluronan-Irinotecan improves progression-free survival in 5-fluorouracil refractory patients with metastatic colorectal cancer: a randomized phase II trial. Cancer Chemother Pharmacol. 2011 Jan;67(1):153-63. doi: 10.1007/s00280-010-1303-3. Epub 2010 Mar 24.
Results Reference
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Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC

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