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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.


Phase 3
18 Years
74 Years
Not Enrolling
Both
Metastatic Colorectal Cancer

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

Every 4th cycle

Safety Issue:

No

Principal Investigator

Kjell M. Tveit, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Professor at Ullevål University Hospital, Norway

Authority:

Norway: Norwegian Medicines Agency

Study ID:

Nordic VII

NCT ID:

NCT00145314

Start Date:

May 2005

Completion Date:

August 2010

Related Keywords:

  • Metastatic Colorectal Cancer
  • Metastatic colorectal cancer
  • FLOX
  • Cetuximab
  • Colorectal Neoplasms

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