NCT00145314

Brief 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. The trial will investigate two regimens of FLOX plus cetuximab, in which FLOX is given continuously or intermittently, compared to standard FLOX without cetuximab.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
571

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 14, 2011

Status Verified

January 1, 2011

Enrollment Period

4 years

First QC Date

September 2, 2005

Last Update Submit

January 13, 2011

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic colorectal cancerFLOXCetuximab

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    Every 2nd week (safety profile)

Study Arms (3)

A

ACTIVE COMPARATOR

FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly

Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin)

B

EXPERIMENTAL

FLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab

Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab

C

EXPERIMENTAL

FLOX given intermittently and maintenance cetuximab

Drug: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab

Interventions

FLOX (5-fluorouracil/folinic acid/oxaliplatin)DRUG

FLOX every 2nd week

A
FLOX (5-fluorouracil/folinic acid/oxaliplatin) and CetuximabDRUG

FLOX every 2nd week Cetuximab weekly

B
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.

C

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • Prior therapy:
  • No prior chemotherapy for advanced/metastatic disease;
  • No previous oxaliplatin;
  • Prior or current history:
  • No current indication for resection with a curative intent;
  • 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:
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Nordic Colorectal Cancer Biomodulation Group

Oslo, NO-0407, Norway

Location

Related Publications (5)

  • 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.

    PMID: 39743478DERIVED

  • 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.

    PMID: 31046124DERIVED

  • 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.

    PMID: 26261061DERIVED

  • 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.

    PMID: 24884501DERIVED

  • 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.

    PMID: 23167843DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

FluorouracilCetuximabLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Officials

  • Kjell M. Tveit, MD, PhD

    Professor at Ullevål University Hospital, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

May 1, 2005

Primary Completion

May 1, 2009

Study Completion

August 1, 2010

Last Updated

January 14, 2011

Record last verified: 2011-01

Locations

NO(1)