Metastatic Colorectal CancerPhase 3NCT00145314

FLOX in Combination With Cetuximab in First-line Treatment of Colorectal Cancer

A Phase 3 study testing FLOX (5-fluorouracil/folinic acid/oxaliplatin), FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab and FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab in people with Metastatic Colorectal Cancer, run by The Nordic Colorectal Cancer Biomodulation Group at 1 site in Norway.

Completed

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

Official record

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Trial summary

The main objective of this trial is to explore the effect of combining an established chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of metastatic colorectal cancer. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Metastatic Colorectal Cancer
What is being tested?: FLOX (5-fluorouracil/folinic acid/oxaliplatin), FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab and FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 571 participants
Where: 1 siteNorway
Study dates: May 2005to Aug 2010
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 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histology and staging disease:
Histological proven adenocarcinoma of the colon or rectum;
At least one measurable metastatic disease
If only one metastatic lesion and no S-CEA elevation, histology is mandatory;
Availability of tumour sample for EGFR assessment.
General conditions:

Show all 11Show fewer

Age >18 and < 75 years;
WHO performance status: life expectancy of more than 3 months;
Adequate haematological function
Adequate renal and hepatic functions
Written informed consent

Who cannot join

Prior therapy:
No prior chemotherapy for advanced/metastatic disease;
No adjuvant chemotherapy the last 6 months before inclusion;
No previous oxaliplatin;
Prior or current history:
No current indication for resection with a curative intent;

Show all 19Show fewer

No evidence of CNS metastasis;
No current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
No current history of chronic diarrhoea;
No peripheral neuropathy;
No other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies);
No past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix;
Concomitant treatments:
No concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation;
No concurrent treatment with any other anti-cancer therapy;
Other:
Not pregnant, no breast feeding
Fertile patients must use adequate contraceptives
Not include patients clearly intending to withdraw from the study if not randomised in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar or geographic reasons.

Trial locations and contacts

1 site in 1 country.

Norway1 site

The Nordic Colorectal Cancer Biomodulation Group
Oslo, NO-0407

Other trials in Norway

About this study

Official title: 5-Fluorouracil/Folinate/Oxaliplatin (Eloxatin) (FLOX Regimen), Given Continuously or Intermittently, in Combination With Cetuximab (Erbitux), in First-line Treatment of Metastatic Colorectal Cancer. A Phase III Multicenter Trial.

Conditions: Metastatic Colorectal Cancer
Being tested: FLOX (5-fluorouracil/folinic acid/oxaliplatin), FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab, FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab
Keywords: Metastatic colorectal cancer, FLOX, Cetuximab
Medical subject headings: Colorectal Neoplasms

What participants receive

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

FLOX (5-fluorouracil/folinic acid/oxaliplatin)Drug
FLOX every 2nd week
FLOX (5-fluorouracil/folinic acid/oxaliplatin) and CetuximabDrug
FLOX every 2nd week Cetuximab weekly
FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximabDrug
FLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced.
Cetuximab weekly.

Study groups in NCT00145314
Study group	Role	What they receive
A	Active comparator	FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly Receives: Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin)
B	Experimental	FLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab Receives: Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab
C	Experimental	FLOX given intermittently and maintenance cetuximab Receives: Drug: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab

What is being measured

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

To compare efficacy, as measured by time to disease progression, of treatment with cetuximab in combination with the FLOX regimen compared to FLOX alone, in first- line treatment of patients with metastatic cororectal cancer
Measured: Every 4th cycle

Secondary outcomes (1)

To measure response rates, response duration, secondary surgical curative resection frequency, safety profile, overall survival and quality of life in the treatment groups.
Measured: Every 2nd week (safety profile)

Timeline

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

May 2005Aug 2010

First posted5 Sep 2005 (estimated)
Study startMay 2005
Primary completionMay 2009
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 571 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00145314
Sponsor's protocol ID: Nordic VII
Other IDs: EudraCT no.: 2005-000117-34
Status last verified: Jan 2011
First submitted: 2 Sep 2005
Last updated: 14 Jan 2011
Results posted: No

Publications

Hamfjord J, Guren TK, Glimelius B, Sorbye H, Pfeiffer P, Dajani O, Lingjaerde OC, Tveit KM, Spindler KG, Pallisgaard N, Kure EH. Exploring Early Kinetic Profiles of CEA, ctDNA and cfDNA in Patients With RAS-/BRAF-Mutated Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2025 Jun;24(2):153-158. doi: 10.1016/j.clcc.2024.11.004. Epub 2024 Dec 3.
PubMed 39743478
Hamfjord J, Guren TK, Dajani O, Johansen JS, Glimelius B, Sorbye H, Pfeiffer P, Lingjaerde OC, Tveit KM, Kure EH, Pallisgaard N, Spindler KG. Total circulating cell-free DNA as a prognostic biomarker in metastatic colorectal cancer before first-line oxaliplatin-based chemotherapy. Ann Oncol. 2019 Jul 1;30(7):1088-1095. doi: 10.1093/annonc/mdz139.
PubMed 31046124
Kjersem JB, Thomsen M, Guren T, Hamfjord J, Carlsson G, Gustavsson B, Ikdahl T, Indrebo G, Pfeiffer P, Lingjaerde O, Tveit KM, Wettergren Y, Kure EH. AGXT and ERCC2 polymorphisms are associated with clinical outcome in metastatic colorectal cancer patients treated with 5-FU/oxaliplatin. Pharmacogenomics J. 2016 Jun;16(3):272-9. doi: 10.1038/tpj.2015.54. Epub 2015 Aug 11.
PubMed 26261061
Kjersem JB, Skovlund E, Ikdahl T, Guren T, Kersten C, Dalsgaard AM, Yilmaz MK, Fokstuen T, Tveit KM, Kure EH. FCGR2A and FCGR3A polymorphisms and clinical outcome in metastatic colorectal cancer patients treated with first-line 5-fluorouracil/folinic acid and oxaliplatin +/- cetuximab. BMC Cancer. 2014 May 19;14:340. doi: 10.1186/1471-2407-14-340.
PubMed 24884501
Kjersem JB, Ikdahl T, Guren T, Skovlund E, Sorbye H, Hamfjord J, Pfeiffer P, Glimelius B, Kersten C, Solvang H, Tveit KM, Kure EH. Let-7 miRNA-binding site polymorphism in the KRAS 3'UTR; colorectal cancer screening population prevalence and influence on clinical outcome in patients with metastatic colorectal cancer treated with 5-fluorouracil and oxaliplatin +/- cetuximab. BMC Cancer. 2012 Nov 20;12:534. doi: 10.1186/1471-2407-12-534.
PubMed 23167843

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
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All Metastatic Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 5-Fluorouracil/Folinate/Oxaliplatin (Eloxatin) (FLOX Regimen), Given Continuously or Intermittently, in Combination With Cetuximab (Erbitux), in First-line Treatment of Metastatic Colorectal Cancer. A Phase III Multicenter Trial.
ClinicalTrials.gov ID: NCT00145314
Acronym / sponsor ID: Nordic VII
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic colorectal cancer, FLOX, Cetuximab
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 571 participants (actual)
Lead sponsor: The Nordic Colorectal Cancer Biomodulation GroupUniversity, hospital or other
Study start: May 2005
Primary completion: May 2009 (actual)
Study completion: Aug 2010 (actual)
First posted: 5 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
A	Active comparator	Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin)FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly
B	Experimental	Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and CetuximabFLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab
C	Experimental	Drug: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximabFLOX given intermittently and maintenance cetuximab

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Histological proven adenocarcinoma of the colon or rectum;
At least one measurable metastatic disease
If only one metastatic lesion and no S-CEA elevation, histology is mandatory;
Availability of tumour sample for EGFR assessment.
Age >18 and < 75 years;

Key exclusion criteria (19 listed)

No prior chemotherapy for advanced/metastatic disease;
No adjuvant chemotherapy the last 6 months before inclusion;
No previous oxaliplatin;
No current indication for resection with a curative intent;
No evidence of CNS metastasis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FLOX (5-fluorouracil/folinic acid/oxaliplatin)FLOX every 2nd week	Drug	A
FLOX (5-fluorouracil/folinic acid/oxaliplatin) and CetuximabFLOX every 2nd week Cetuximab weekly	Drug	B
FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximabFLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced. Cetuximab weekly.	Drug	C

Primary outcome

To compare efficacy, as measured by time to disease progression, of treatment with cetuximab in combination with the FLOX regimen compared to FLOX alone, in first- line treatment of patients with metastatic cororectal cancer
Time frame: Every 4th cycle

1 secondary outcome

To measure response rates, response duration, secondary surgical curative resection frequency, safety profile, overall survival and quality of life in the treatment groups.
Time frame: Every 2nd week (safety profile)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2011.
Derived from this study: PubMed 39743478Hamfjord J, Guren TK, Glimelius B, Sorbye H, Pfeiffer P, Dajani O, Lingjaerde OC, Tveit KM, Spindler KG, Pallisgaard N, Kure EH. Exploring Early Kinetic Profiles of CEA, ctDNA and cfDNA in Patients With RAS-/BRAF-Mutated Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2025 Jun;24(2):153-158. doi: 10.1016/j.clcc.2024.11.004. Epub 2024 Dec 3.
Derived from this study: PubMed 31046124Hamfjord J, Guren TK, Dajani O, Johansen JS, Glimelius B, Sorbye H, Pfeiffer P, Lingjaerde OC, Tveit KM, Kure EH, Pallisgaard N, Spindler KG. Total circulating cell-free DNA as a prognostic biomarker in metastatic colorectal cancer before first-line oxaliplatin-based chemotherapy. Ann Oncol. 2019 Jul 1;30(7):1088-1095. doi: 10.1093/annonc/mdz139.
Derived from this study: PubMed 26261061Kjersem JB, Thomsen M, Guren T, Hamfjord J, Carlsson G, Gustavsson B, Ikdahl T, Indrebo G, Pfeiffer P, Lingjaerde O, Tveit KM, Wettergren Y, Kure EH. AGXT and ERCC2 polymorphisms are associated with clinical outcome in metastatic colorectal cancer patients treated with 5-FU/oxaliplatin. Pharmacogenomics J. 2016 Jun;16(3):272-9. doi: 10.1038/tpj.2015.54. Epub 2015 Aug 11.
Derived from this study: PubMed 24884501Kjersem JB, Skovlund E, Ikdahl T, Guren T, Kersten C, Dalsgaard AM, Yilmaz MK, Fokstuen T, Tveit KM, Kure EH. FCGR2A and FCGR3A polymorphisms and clinical outcome in metastatic colorectal cancer patients treated with first-line 5-fluorouracil/folinic acid and oxaliplatin +/- cetuximab. BMC Cancer. 2014 May 19;14:340. doi: 10.1186/1471-2407-14-340.
Derived from this study: PubMed 23167843Kjersem JB, Ikdahl T, Guren T, Skovlund E, Sorbye H, Hamfjord J, Pfeiffer P, Glimelius B, Kersten C, Solvang H, Tveit KM, Kure EH. Let-7 miRNA-binding site polymorphism in the KRAS 3'UTR; colorectal cancer screening population prevalence and influence on clinical outcome in patients with metastatic colorectal cancer treated with 5-fluorouracil and oxaliplatin +/- cetuximab. BMC Cancer. 2012 Nov 20;12:534. doi: 10.1186/1471-2407-12-534.

Related trials for Metastatic Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
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RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kjell M. Tveit, MD, PhD principal investigator

Professor at Ullevål University Hospital, Norway

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. 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 14 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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?

To compare efficacy, as measured by time to disease progression, of treatment with cetuximab in combination with the FLOX regimen compared to FLOX alone, in first- line treatment of patients with metastatic cororectal cancer (time frame: Every 4th cycle). 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 NCT00145314, which also lists 5 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 14 Jan 2011.