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

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ClinicalTrials.gov Identifier: NCT00145314
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : January 14, 2011
Sponsor:
Information provided by:
The Nordic Colorectal Cancer Biomodulation Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab Drug: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 571 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : May 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : August 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly
 Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin)
FLOX every 2nd week
Experimental: B
FLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab
 Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab
FLOX every 2nd week Cetuximab weekly
Experimental: C
FLOX given intermittently and maintenance cetuximab
 Drug: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab

FLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced.

Cetuximab weekly.


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: Every 4th cycle ]

Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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;
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145314


Locations
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Norway
The Nordic Colorectal Cancer Biomodulation Group
Oslo, Norway, NO-0407
Sponsors and Collaborators
The Nordic Colorectal Cancer Biomodulation Group
Investigators
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Principal Investigator: Kjell M. Tveit, MD, PhD Professor at Ullevål University Hospital, Norway
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kjell M. Tveit, MD, PhD, The Nordic Colorectal Cancer Biomodulation Group
ClinicalTrials.gov Identifier: NCT00145314    
Other Study ID Numbers: Nordic VII
EudraCT no.: 2005-000117-34
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: January 14, 2011
Last Verified: January 2011
Keywords provided by The Nordic Colorectal Cancer Biomodulation Group:
Metastatic colorectal cancer
FLOX
Cetuximab
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Folic Acid
Fluorouracil
Oxaliplatin
 Cetuximab
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients