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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01290783




Trial ID
NCT01290783
Ethics application status
Date submitted
31/01/2011
Date registered
4/02/2011
Date last updated
28/04/2015

Titles & IDs
Public title
Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC
Scientific 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
Secondary ID [1] 0 0
ACO-002
Universal Trial Number (UTN)
Trial acronym
FOLF(HA)iri
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Irintoecan
Treatment: Drugs - HA-Irinotecan solution for Infusion

Active Comparator: FOLFIRI -

Experimental: FOLF(HA)iri -


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Approximately 20 months
Secondary outcome [1] 0 0
Safety - Diarrhea and haematology
Timepoint [1] 0 0
After initial 20 patients receive 2 cycles, then 6 monthly thereafter.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [2] 0 0
Western General Hospital - Melbourne
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [4] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [5] 0 0
Border Medical Oncology - Wodonga
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
3011 - Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment postcode(s) [4] 0 0
3165 - Melbourne
Recruitment postcode(s) [5] 0 0
3690 - Wodonga

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alchemia Oncology
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01290783
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Peter Gibbs, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries