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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/NCT02216487




Registration number
NCT02216487
Ethics application status
Date submitted
12/08/2014
Date registered
15/08/2014
Date last updated
29/08/2014

Titles & IDs
Public title
Trial of FOLF(HA)Iri With Cetuximab in mCRC
Scientific title
Phase II Single Arm Trial of FOLF(HA)Iri Plus Cetuximab in Irinotecan-naïve Second Line Patients With KRAS Wild Type Metastatic Colorectal Cancer
Secondary ID [1] 0 0
ACO-004
Universal Trial Number (UTN)
Trial acronym
Chime
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 - HA-Irinotecan

Experimental: HA-Irinotecan - HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan.


Treatment: Drugs: HA-Irinotecan
HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
Inclusion criteria

- Tumour is KRAS wild type

- mCRC with disease progression after first-line chemotherapy (adjuvant chemotherapy is
considered first line chemotherapy if metastatic progression occurs within 6 months of
the end of the adjuvant chemotherapy).

- Irinotecan naïve

- Prior use of bevacizumab in the 1st line setting is permitted.

- ECOG 0 or 1

- Measurable disease

- Histological proof of colorectal adenocarcinoma

- 18+ years of age

- Adequately recovered from and at least 4 weeks after recent major surgery or
chemotherapy

- At least 4 weeks after treatment with a biologic monotherapy from last dose to
enrolment.

- Hematology done within 14 days prior to enrolment :

- Absolute Neutrophil count (ANC) greater than 1.5 x 109/L

- Platelets greater than 100 x 109/L

- Hemoglobin greater than or equal to 100g/L

- Chemistry done within 14 days prior to enrolment:

- AST greater than or equal to 2.5 X ULN (greater than 5 X ULN if elevation thought
to be related to hepatic metastatic disease),

- Alkaline phosphatase greater than 5 x ULN,

- Serum creatinine greater than 1.5 x ULN,

- Total bilirubin greater than 34.2 µmol/L,

- Negative serum or urine pregnancy test if a WOCBP.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- KRAS mutant.

- Prior irinotecan

- Prior anti-EGFR

- History of other malignancies, except adequately treated non-melanoma skin cancer,
curatively treated in-situ cancer of the cervix, or other solid tumours curatively
treated with no evidence of disease for greater than 5 years.

- Locally advanced or recurrent disease only

- Unsuitability for irinotecan

- Abdominal or pelvic radiation therapy (including treatment with SIR-Spheres/Sirtex)
within the last 12 months.

- Women who are pregnant or breastfeeding.

- Significant cardiac disease

- Untreated or symptomatic brain or central nervous system (CNS) metastases

- Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or
paracentesis.

- Current partial or complete bowel obstruction.

- Concomitant active infection.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
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
1/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2016
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [2] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [3] 0 0
Western General Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
1871 - Sydney
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3021 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Western General Hospital, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Alchemia Oncology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Merck Serono International SA
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing
chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for
delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of
hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in
optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific
example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced
efficacy in both nonclinical and early clinical studies.

The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm
trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild
type metastatic colorectal cancer. The study objectives are to confirm the safety and
efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic
colorectal cancer patients.

It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent
treatment and follow up; thus the trial will run for approximately 2-3 years.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02216487
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Gibbs, MD
Address 0 0
Western General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter Gibbs, MD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02216487