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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01290783




Registration number
NCT01290783
Ethics application status
Date submitted
31/01/2011
Date registered
7/02/2011
Date last updated
29/04/2015

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
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
Sex
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
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2015
Actual
Sample size
Target
390
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/ct2/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01290783