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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00079066




Registration number
NCT00079066
Ethics application status
Date submitted
8/03/2004
Date registered
9/03/2004

Titles & IDs
Public title
Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
Scientific title
A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma
Secondary ID [1] 0 0
CAN-NCIC-CO17
Secondary ID [2] 0 0
CO17
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Quality of Life 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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Time to progression
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Objective response rate
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Quality of life by European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire -C30 (EORTC QLQ-C30)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Health utilities by Health Utilities Index 13 (HU 13)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Economic evaluation
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Safety profile
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* 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 (e.g., 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
* No symptomatic CNS metastases NOTE: *Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen

PATIENT CHARACTERISTICS:

Age

* 16 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* See Disease Characteristics
* Absolute granulocyte count = 1,500/mm^3
* Platelet count = 75,000/mm^3
* Hemoglobin = 8.0 g/dL

Hepatic

* AST and ALT = 5 times upper limit of normal (ULN)
* Bilirubin = 2.5 times ULN

Renal

* Creatinine = 1.5 times ULN

Cardiovascular

* No uncontrolled angina
* No arrhythmias
* No cardiomyopathy
* No congestive heart failure
* No myocardial infarction* within the past 6 months NOTE: *Pre-treatment ECG as only evidence of infarction is allowed

Pulmonary

* No severe restrictive lung disease
* No interstitial lung disease by chest x-ray

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment
* No active pathological condition that would preclude study participation
* No psychological or geographical condition that would preclude study compliance
* No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior cetuximab
* No prior murine monoclonal antibody therapy (e.g., edrecolomab)

Chemotherapy

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy and recovered
* No concurrent chemotherapy

Radiotherapy

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* Concurrent palliative radiotherapy allowed except to index lesions

Surgery

* At least 4 weeks since prior major surgery and recovered

Other

* No prior EGFR-targeted therapy (e.g., erlotinib or gefitinib)
* More than 30 days since prior experimental therapeutic agents
* More than 4 weeks since prior investigational agents
* No concurrent enrollment in another clinical study
* No other concurrent EGFR-targeted therapy
* No other concurrent non-cytotoxic experimental agents
Minimum age
16 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/02/2009
Sample size
Target
Accrual to date
Final
572
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
NHMRC Clinical Trials Centre - Camperdown
Recruitment postcode(s) [1] 0 0
1450 - Camperdown
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Newfoundland and Labrador
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Prince Edward Island
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Canada
State/province [10] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
NCIC Clinical Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Gastro-Intestinal Trials Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Derek Jonker, MD
Address 0 0
Ottawa Regional Cancer Centre
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT00079066