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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02216487