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Colorectal CancerPhase 3NCT00079066

Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer

A Phase 3 study testing cetuximab and quality-of-life assessment in people with Colorectal Cancer and Quality of Life, run by NCIC Clinical Trials Group at 33 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 120 years
Conditions the study is for
Colorectal Cancer, Quality of Life
What is being tested?
cetuximab and quality-of-life assessment
Type of treatment
Surgery or procedure
How many people
572 participants
Where
33 sitesin 2 countries
Study dates
30 Dec 2003to 10 Feb 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

33 sites in 2 countries.

33 sites in 2 countries

Canada32 sites

  • Belleville General Hospital

    Belleville, Ontario, K8N 5K5

  • Prince Edward Island Cancer Centre at Queen Elizabeth Hospital

    Charlottetown, Prince Edward Island, C1A 8T5

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • Grand River Regional Cancer Centre at Grand River Hospital

    Kitchener, Ontario, N2G 1G3

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6ZB

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4MI

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Hospital Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre at the University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 4H4

  • Hotel Dieu Health Sciences Hospital - Niagara

    St. Catharines, Ontario, L2R 5K3

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Fraser Valley Cancer Centre at British Columbia Cancer Agency

    Surrey, British Columbia, V3V 1Z2

  • Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital - Toronto

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • St. Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

  • Windsor Regional Cancer Centre at Windsor Regional Hospital

    Windsor, Ontario, N8W 2X3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Australia1 site

  • NHMRC Clinical Trials Centre

    Camperdown, New South Wales, 1450

Other trials in Australia

About this study

Official 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

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.

Read the detailed description

OBJECTIVES:

Primary

  • 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.

Secondary

  • Compare the time to disease progression in patients treated with these regimens.
  • Compare the objective response rate in patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the health utilities of patients treated with these regimens.
  • Conduct a comparative economic evaluation in patients treated with these regimens.
  • Determine the safety profile of cetuximab in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive an initial loading dose of cetuximab 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 hospitalization for end-of-life care).

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 20 months.

Being tested
cetuximab, quality-of-life assessment
Keywords
quality of life, stage IV colon cancer, recurrent colon cancer, recurrent rectal cancer, stage IV rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximabBiological

  • quality-of-life assessmentProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

Secondary outcomes (6)

  1. Time to progression

  2. Objective response rate

  3. Quality of life by European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire -C30 (EORTC QLQ-C30)

  4. Health utilities by Health Utilities Index 13 (HU 13)

  5. Economic evaluation

  6. Safety profile

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2004 (estimated)
  2. Study start30 Dec 2003
  3. Primary completion3 Nov 2006
  4. Study completion10 Feb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
572 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00079066
Sponsor's protocol ID
CO17
Other IDs
CAN-NCIC-CO17, AGITG-CAN-NCIC-CO17, BMS-CA225-025, IMCL-CAN-NCIC-CO17, CDR0000353486
Status last verified
Apr 2020
First submitted
8 Mar 2004
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 36881786

  • Au HJ, Karapetis CS, O'Callaghan CJ, Tu D, Moore MJ, Zalcberg JR, Kennecke H, Shapiro JD, Koski S, Pavlakis N, Charpentier D, Wyld D, Jefford M, Knight GJ, Magoski NM, Brundage MD, Jonker DJ. Health-related quality of life in patients with advanced colorectal cancer treated with cetuximab: overall and KRAS-specific results of the NCIC CTG and AGITG CO.17 Trial. J Clin Oncol. 2009 Apr 10;27(11):1822-8. doi: 10.1200/JCO.2008.19.6048. Epub 2009 Mar 9.

    PubMed 19273701

  • Jonker DJ, Karapetis C, Harbison C, et al.: High epiregulin (EREG) gene expression plus K-ras wild-type (WT) status as predictors of cetuximab benefit in the treatment of advanced colorectal cancer (ACRC): results from NCIC CTG CO.17-A phase III trial of cetuximab versus best supportive care (BSC).. [Abstract] J Clin Oncol 27 (Suppl 15): A-4016, 2009.

  • Asmis TR, Powell E, Karapetis CS, Jonker DJ, Tu D, Jeffery M, Pavlakis N, Gibbs P, Zhu L, Dueck DA, Whittom R, Langer C, O'Callaghan CJ. Comorbidity, age and overall survival in cetuximab-treated patients with advanced colorectal cancer (ACRC)--results from NCIC CTG CO.17: a phase III trial of cetuximab versus best supportive care. Ann Oncol. 2011 Jan;22(1):118-126. doi: 10.1093/annonc/mdq309. Epub 2010 Jul 5.

    PubMed 20603436

  • Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S, Price TJ, Shepherd L, Au HJ, Langer C, Moore MJ, Zalcberg JR. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008 Oct 23;359(17):1757-65. doi: 10.1056/NEJMoa0804385.

    PubMed 18946061

  • Mittmann N, Au HJ, Tu D, et al.: A prospective economic analysis of cost-effectiveness of cetuximab for metastatic colorectal cancer patients from the NCIC CTG and AGITG CO.17 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-6528, 2008.

  • O'Callaghan CJ, Tu D, Karapetis CS, et al.: The relationship between the development of rash and clinical and quality of life outcomes in colorectal cancer patients treated with cetuximab in NCIC CTG CO.17. [Abstract] J Clin Oncol 26 (Suppl 15): A-4130, 2008.

  • Jonker DJ, Karapetis CS, Moore M, et al.: Randomized phase III trial of cetuximab monotherapy plus best supportive care (BSC) versus BSC alone in patients with pretreated metastatic epidermal growth factor receptor (EGFR)-positive colorectal carcinoma: a trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) and the Australasian Gastro-Intestinal Trials Group (AGITG). [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. 2007.

  • Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ, Berry SR, Krahn M, Price T, Simes RJ, Tebbutt NC, van Hazel G, Wierzbicki R, Langer C, Moore MJ. Cetuximab for the treatment of colorectal cancer. N Engl J Med. 2007 Nov 15;357(20):2040-8. doi: 10.1056/NEJMoa071834.

    PubMed 18003960

  • Nicholls DL, Xu MC, Zhan L, Sharma D, Hueniken K, Chiasson K, Wahba M, Brown MC, Grant B, Shapiro J, Karapetis CS, Simes J, Jonker D, Tu D, O'Callaghan C, Chen E, Liu G. Machine Learning Models of Early Longitudinal Toxicity Trajectories Predict Cetuximab Concentration and Metastatic Colorectal Cancer Survival in the Canadian Cancer Trials Group/AGITG CO.17/20 Trials. JCO Clin Cancer Inform. 2025 Apr;9:e2400114. doi: 10.1200/CCI.24.00114. Epub 2025 Apr 11.

    PubMed 40215447

  • 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. The association of health-care contact days with physical function and survival in CCTG/AGITG CO.17. J Natl Cancer Inst. 2024 Aug 1;116(8):1313-1318. doi: 10.1093/jnci/djae077.

    PubMed 38656931

  • Loree JM, Dowers A, Tu D, Jonker DJ, Edelstein DL, Quinn H, Holtrup F, Price T, Zalcberg JR, Moore MJ, Karapetis CS, O'Callaghan CJ, Waring P, Kennecke HF, Hamilton SR, Kopetz S. Expanded Low Allele Frequency RAS and BRAF V600E Testing in Metastatic Colorectal Cancer as Predictive Biomarkers for Cetuximab in the Randomized CO.17 Trial. Clin Cancer Res. 2021 Jan 1;27(1):52-59. doi: 10.1158/1078-0432.CCR-20-2710. Epub 2020 Oct 21.

    PubMed 33087330

  • Hay AE, Pater JL, Corn E, Han L, Camacho X, O'Callaghan C, Chong N, Bell EN, Tu D, Earle CC. Pilot study of the ability to probabilistically link clinical trial patients to administrative data and determine long-term outcomes. Clin Trials. 2019 Feb;16(1):14-17. doi: 10.1177/1740774518815653. Epub 2018 Nov 22.

    PubMed 30466310

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cetuximab and quality-of-life assessment in people with Colorectal Cancer and Quality of Life, run by NCIC Clinical Trials Group at 33 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00079066, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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