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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/NCT00079066
Registration number
NCT00079066
Ethics application status
Date submitted
8/03/2004
Date registered
9/03/2004
Date last updated
4/08/2023
Titles & IDs
Public title
Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
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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
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Secondary ID [1]
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CAN-NCIC-CO17
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Secondary ID [2]
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CO17
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
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Quality of Life
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - cetuximab
Treatment: Surgery - quality-of-life assessment
Other interventions: cetuximab
Treatment: Surgery: quality-of-life assessment
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Time to progression
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Objective response rate
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Quality of life by European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire -C30 (EORTC QLQ-C30)
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Health utilities by Health Utilities Index 13 (HU 13)
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Economic evaluation
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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Safety profile
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Assessment method [6]
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Timepoint [6]
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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
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Minimum age
16
Years
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Maximum age
120
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/12/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/02/2009
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Sample size
Target
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Accrual to date
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Final
572
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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NHMRC Clinical Trials Centre - Camperdown
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Recruitment postcode(s) [1]
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1450 - Camperdown
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Recruitment outside Australia
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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New Brunswick
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Country [5]
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Canada
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Newfoundland and Labrador
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Country [6]
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Canada
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State/province [6]
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Nova Scotia
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Country [7]
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Canada
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State/province [7]
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Ontario
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Country [8]
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Canada
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Prince Edward Island
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Canada
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Quebec
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Country [10]
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Canada
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State/province [10]
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Saskatchewan
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Funding & Sponsors
Primary sponsor type
Other
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Name
NCIC Clinical Trials Group
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australasian Gastro-Intestinal Trials Group
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill
them or deliver tumor-killing substances to them without harming normal cells. Best
supportive care is the use of drugs and other treatments to improve the quality of life of
patients. Combining cetuximab with best supportive care may slow the growth of the tumor and
help patients live longer and more comfortably. It is not yet known whether cetuximab
combined with best supportive care is more effective than best supportive care alone in
treating metastatic epidermal growth factor receptor-positive colorectal cancer.
PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to
see how well they work compared to best supportive care alone in treating patients with
metastatic epidermal growth factor receptor-positive colorectal cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00079066
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Trial related presentations / publications
Gupta A, O'Callaghan CJ, Zhu L, Jonker DJ, Wong RPW, Colwell B, Moore MJ, Karapetis CS, Tebbutt NC, Shapiro JD, Tu D, Booth CM. Evaluating the Time Toxicity of Cancer Treatment in the CCTG CO.17 Trial. JCO Oncol Pract. 2023 Jun;19(6):e859-e866. doi: 10.1200/OP.22.00737. Epub 2023 Mar 7.
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Public notes
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Contacts
Principal investigator
Name
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Derek Jonker, MD
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Address
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Ottawa Regional Cancer Centre
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00079066
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