Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000112561
Ethics application status
Approved
Date submitted
28/07/2004
Date registered
28/07/2004
Date last updated
21/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cetuximab and Best Supportive Care Compared with Best Supportive Care Alone in Treating Patients with Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer.
Scientific title
Phase III Randomised Study of Cetuximab and Best Supportive Care Versus Best Supportive Care Alone in survival of Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer.
Secondary ID [1] 75 0
Bristol Myers-Squibb, Canada: BMS-CA225-025
Secondary ID [2] 76 0
ImClone: IMCL-CAN-NCIC-CO17
Secondary ID [3] 78 0
National Clinical Trials Registry: NCTR576
Secondary ID [4] 248 0
National Cancer Institute of Canada: CAN-NCIC-CO17
Secondary ID [5] 249 0
Bristol Myers Squibb, Canada: BMS-CA225-025
Secondary ID [6] 251 0
Australasian Gastro-Intestinal Trials Group: AGITG-CAN-NCIC-CO17
Universal Trial Number (UTN)
Trial acronym
CO.17
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
- stage IV colon cancer
- recurrent colon cancer
- recurrent rectal cancer
- stage IV rectal cancer 62 0
Condition category
Condition code
Cancer 73 73 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomised to 1 of 2 treatment arms.

Arm I: Patients receive an initial loading dose of cetuximab (Erbitux) IV over 120 minutes on day 1. Patients continue to receive maintenance infusions of cetuximab IV over 60 minutes weekly. Patients also receive best supportive care, defined as measures designed to provide palliation of symptoms and improve quality of life as much as possible.

Arm II: Patients receive best supportive care as in arm I. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, and then at 4, 8, 16, and 24 weeks (or until deterioration to ECOG PS 4 or hospitalisation for end of life care). Patients are followed up every 4 weeks.
Intervention code [1] 823 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1558 0
Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care alone.
Timepoint [1] 1558 0
Measured from enrolment
Secondary outcome [1] 2805 0
Compare the time to disease progression in patients treated with these regimens.
Timepoint [1] 2805 0
Secondary outcome [2] 2806 0
Compare the objective response rate in patients treated with these regimens.
Timepoint [2] 2806 0
Secondary outcome [3] 2807 0
Compare the quality of life of patients treated with these regimens.
Timepoint [3] 2807 0
At week 4, 8, 16 and 24 of treatment.
Secondary outcome [4] 2808 0
Compare the health utilities of patients treated with these regimens throughought treatment and follow up.
Timepoint [4] 2808 0
Secondary outcome [5] 2809 0
Conduct a comparative economic evaluation in patients treated with these regimens, throughtout treatment and follow up.
Timepoint [5] 2809 0
Secondary outcome [6] 2810 0
Determine the safety profile of cetuximab in these patients throughout treatment and follow up.
Timepoint [6] 2810 0

Eligibility
Key inclusion criteria
Histologically confirmed colorectal cancer- Metastatic disease- Epidermal growth factor receptor (EGFR)-positive by immunochemistry- Measurable or evaluable disease- Not amenable to standard curative therapy- Best supportive care is the only available option- Must have received a prior thymidylate synthase inhibitor (eg: fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting- Combination therapy with oxaliplatin or irinotecan allowed- Must have failed* a prior regimen containing irinotecan and a prior regimen containing oxaliplatin for metastatic disease OR relapsed within 6 months after an adjuvant regimen containing irinotecan or oxaliplatin OR have documented unsuitability for such regimens.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No symptomatic CNS metastases.- Any condition that does not permit compliance with the protocol*NOTE: Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen.

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)
Central Randomisation by fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic Minimisation Procedure
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 103 0
Government body
Name [1] 103 0
National Cancer Institute of Canada
Country [1] 103 0
Canada
Funding source category [2] 1265 0
Other
Name [2] 1265 0
National Cancer Institute of Canada
Country [2] 1265 0
Canada
Primary sponsor type
Charities/Societies/Foundations
Name
National Cancer Institute of Canada
Address
Country
Canada
Secondary sponsor category [1] 1120 0
Other Collaborative groups
Name [1] 1120 0
Australasian Gastro-Intestinal Trials Group
Address [1] 1120 0
Country [1] 1120 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 741 0
The Canberra Hospital
Ethics committee address [1] 741 0
Ethics committee country [1] 741 0
Australia
Date submitted for ethics approval [1] 741 0
Approval date [1] 741 0
29/10/2003
Ethics approval number [1] 741 0
Ethics committee name [2] 742 0
Royal North Shore Hospital
Ethics committee address [2] 742 0
Ethics committee country [2] 742 0
Australia
Date submitted for ethics approval [2] 742 0
Approval date [2] 742 0
Ethics approval number [2] 742 0
Ethics committee name [3] 743 0
Prince of Wales Hospital
Ethics committee address [3] 743 0
Ethics committee country [3] 743 0
Australia
Date submitted for ethics approval [3] 743 0
Approval date [3] 743 0
26/08/2003
Ethics approval number [3] 743 0
Ethics committee name [4] 744 0
St George Hospital
Ethics committee address [4] 744 0
Ethics committee country [4] 744 0
Australia
Date submitted for ethics approval [4] 744 0
Approval date [4] 744 0
10/10/2003
Ethics approval number [4] 744 0
Ethics committee name [5] 745 0
Newcastle Hospital
Ethics committee address [5] 745 0
Ethics committee country [5] 745 0
Australia
Date submitted for ethics approval [5] 745 0
Approval date [5] 745 0
02/07/2004
Ethics approval number [5] 745 0
Ethics committee name [6] 746 0
Nepean Hospital
Ethics committee address [6] 746 0
Ethics committee country [6] 746 0
Australia
Date submitted for ethics approval [6] 746 0
Approval date [6] 746 0
28/08/2003
Ethics approval number [6] 746 0
Ethics committee name [7] 747 0
Port Macquarie Base Hospital
Ethics committee address [7] 747 0
Ethics committee country [7] 747 0
Australia
Date submitted for ethics approval [7] 747 0
Approval date [7] 747 0
25/08/2003
Ethics approval number [7] 747 0
Ethics committee name [8] 748 0
Royal Melbourne Hospital
Ethics committee address [8] 748 0
Ethics committee country [8] 748 0
Australia
Date submitted for ethics approval [8] 748 0
Approval date [8] 748 0
21/04/2004
Ethics approval number [8] 748 0
Ethics committee name [9] 749 0
Peter MacCallum Cancer Institute
Ethics committee address [9] 749 0
Ethics committee country [9] 749 0
Australia
Date submitted for ethics approval [9] 749 0
Approval date [9] 749 0
16/09/2003
Ethics approval number [9] 749 0
Ethics committee name [10] 750 0
St Vincent's Hospital
Ethics committee address [10] 750 0
Ethics committee country [10] 750 0
Australia
Date submitted for ethics approval [10] 750 0
Approval date [10] 750 0
25/09/2003
Ethics approval number [10] 750 0
Ethics committee name [11] 751 0
The Alfred Hospital
Ethics committee address [11] 751 0
Ethics committee country [11] 751 0
Australia
Date submitted for ethics approval [11] 751 0
Approval date [11] 751 0
17/09/2003
Ethics approval number [11] 751 0
Ethics committee name [12] 752 0
Austin and Repatriation Medical Centre
Ethics committee address [12] 752 0
Ethics committee country [12] 752 0
Australia
Date submitted for ethics approval [12] 752 0
Approval date [12] 752 0
23/10/2003
Ethics approval number [12] 752 0
Ethics committee name [13] 753 0
Monash Medical Centre
Ethics committee address [13] 753 0
Ethics committee country [13] 753 0
Australia
Date submitted for ethics approval [13] 753 0
Approval date [13] 753 0
02/02/2004
Ethics approval number [13] 753 0
Ethics committee name [14] 754 0
Border Medical Oncology
Ethics committee address [14] 754 0
Ethics committee country [14] 754 0
Australia
Date submitted for ethics approval [14] 754 0
Approval date [14] 754 0
10/12/2003
Ethics approval number [14] 754 0
Ethics committee name [15] 755 0
Cabrini Hospital
Ethics committee address [15] 755 0
Ethics committee country [15] 755 0
Australia
Date submitted for ethics approval [15] 755 0
Approval date [15] 755 0
08/09/2003
Ethics approval number [15] 755 0
Ethics committee name [16] 756 0
Royal Brisbane Hospital
Ethics committee address [16] 756 0
Ethics committee country [16] 756 0
Australia
Date submitted for ethics approval [16] 756 0
Approval date [16] 756 0
12/12/2003
Ethics approval number [16] 756 0
Ethics committee name [17] 757 0
Brisbane Adult Mater Hospital
Ethics committee address [17] 757 0
Ethics committee country [17] 757 0
Australia
Date submitted for ethics approval [17] 757 0
Approval date [17] 757 0
18/02/2004
Ethics approval number [17] 757 0
Ethics committee name [18] 758 0
Flinders Medical Centre
Ethics committee address [18] 758 0
Ethics committee country [18] 758 0
Australia
Date submitted for ethics approval [18] 758 0
Approval date [18] 758 0
25/08/2003
Ethics approval number [18] 758 0
Ethics committee name [19] 759 0
The Queen Elizabeth Hospital
Ethics committee address [19] 759 0
Ethics committee country [19] 759 0
Australia
Date submitted for ethics approval [19] 759 0
Approval date [19] 759 0
09/12/2003
Ethics approval number [19] 759 0
Ethics committee name [20] 760 0
Sir Charles Gairdner Hospital
Ethics committee address [20] 760 0
Ethics committee country [20] 760 0
Australia
Date submitted for ethics approval [20] 760 0
Approval date [20] 760 0
07/08/2003
Ethics approval number [20] 760 0
Ethics committee name [21] 761 0
Royal Perth Hospital
Ethics committee address [21] 761 0
Ethics committee country [21] 761 0
Australia
Date submitted for ethics approval [21] 761 0
Approval date [21] 761 0
16/03/2004
Ethics approval number [21] 761 0
Ethics committee name [22] 762 0
Fremantle Hospital
Ethics committee address [22] 762 0
Ethics committee country [22] 762 0
Australia
Date submitted for ethics approval [22] 762 0
Approval date [22] 762 0
16/09/2003
Ethics approval number [22] 762 0
Ethics committee name [23] 763 0
St John of God Hospital
Ethics committee address [23] 763 0
Ethics committee country [23] 763 0
Australia
Date submitted for ethics approval [23] 763 0
Approval date [23] 763 0
07/08/2003
Ethics approval number [23] 763 0
Ethics committee name [24] 764 0
Royal Hobart Hospital
Ethics committee address [24] 764 0
Ethics committee country [24] 764 0
Australia
Date submitted for ethics approval [24] 764 0
Approval date [24] 764 0
01/10/2003
Ethics approval number [24] 764 0
Ethics committee name [25] 765 0
Launceston General Hospital
Ethics committee address [25] 765 0
Ethics committee country [25] 765 0
Australia
Date submitted for ethics approval [25] 765 0
Approval date [25] 765 0
06/11/2003
Ethics approval number [25] 765 0
Ethics committee name [26] 766 0
Christchurch Hospital
Ethics committee address [26] 766 0
Ethics committee country [26] 766 0
New Zealand
Date submitted for ethics approval [26] 766 0
Approval date [26] 766 0
15/03/2004
Ethics approval number [26] 766 0
Ethics committee name [27] 767 0
Palmerston North Hospital
Ethics committee address [27] 767 0
Ethics committee country [27] 767 0
New Zealand
Date submitted for ethics approval [27] 767 0
Approval date [27] 767 0
08/03/2004
Ethics approval number [27] 767 0
Ethics committee name [28] 768 0
National Cancer Centre
Ethics committee address [28] 768 0
Ethics committee country [28] 768 0
Singapore
Date submitted for ethics approval [28] 768 0
Approval date [28] 768 0
10/05/2004
Ethics approval number [28] 768 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35814 0
Address 35814 0
Country 35814 0
Phone 35814 0
Fax 35814 0
Email 35814 0
Contact person for public queries
Name 10012 0
Dr Chris Karapetis
Address 10012 0
Department of Medical Oncology
Flinders Medical Centre
Flinders Drive
Bedford Park Adelaide SA 5042
Country 10012 0
Australia
Phone 10012 0
+61 8 82048997
Fax 10012 0
+61 8 82044997
Email 10012 0
[email protected]
Contact person for scientific queries
Name 940 0
Dr Chris Karapetis
Address 940 0
Department of Medical Oncology
Flinders Medical Centre
Flinders Drive
Bedford Park Adelaide SA 5042
Country 940 0
Australia
Phone 940 0
+61 8 82048997
Fax 940 0
+61 8 82044997
Email 940 0
[email protected]

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

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