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

This study has been completed.
Sponsor:
Information provided by:
The Nordic Colorectal Cancer Biomodulation Group
ClinicalTrials.gov Identifier:
NCT00145314
First received: September 2, 2005
Last updated: January 13, 2011
Last verified: January 2011
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by The Nordic Colorectal Cancer Biomodulation Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 571
Study Start Date: May 2005
Study Completion Date: August 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145314

Locations
Norway
The Nordic Colorectal Cancer Biomodulation Group
Oslo, Norway, NO-0407
Sponsors and Collaborators
The Nordic Colorectal Cancer Biomodulation Group
Investigators
Principal Investigator: Kjell M. Tveit, MD, PhD Professor at Ullevål University Hospital, Norway
  More Information

No publications provided

Responsible Party: Kjell M. Tveit, MD, PhD, The Nordic Colorectal Cancer Biomodulation Group
ClinicalTrials.gov Identifier: NCT00145314     History of Changes
Other Study ID Numbers: Nordic VII, EudraCT no.: 2005-000117-34
Study First Received: September 2, 2005
Last Updated: January 13, 2011
Health Authority: Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Denmark: National Board of Health
Finland: Finnish Medicines Agency

Keywords provided by The Nordic Colorectal Cancer Biomodulation Group:
Metastatic colorectal cancer
FLOX
Cetuximab

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Oxaliplatin
Fluorouracil
Levoleucovorin
Folic Acid
Leucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on September 16, 2014