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FLOX + Cetuximab (Erbitux®): First Line Treatment for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor, A Phase II Study

Phase 2
18 Years
75 Years
Open (Enrolling)
Metastatic Colorectal Cancer

Thank you

Trial Information

FLOX + Cetuximab (Erbitux®): First Line Treatment for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor, A Phase II Study

Inclusion Criteria:

Histology and staging disease:

- Histological proven adenocarcinoma of the colon or rectum

- At least one measurable metastatic lesion according to RECIST criteria

- If only one metastatic lesion, histology is mandatory

Mutation level:

- Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in
codon 12 and 13 in exon 1 at real-time PCR

General conditions:

- Age >18 and < 75 years

- WHO performance status ≤ 2; life expectancy of more than 3 months

- Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥
100 x 109/L)

- Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit,
creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x
upper normal limits in case of liver metastases

- Written informed consent prior to randomisation must be obtained and documented
according to the local regulatory requirements


- Fertile patients must use adequate contraceptives

Exclusion Criteria:

Prior therapy:

- Prior chemotherapy for advanced/metastatic disease

- Adjuvant chemotherapy must have ended > 6 months before inclusion

- Prior treatment with Eloxatin

- Prior treatment with Erbitux or other treatment to EGFR

Prior or current history:

- Current indication for resection with a curative intent

- Evidence of CNS metastasis

- Current infection, unresolved bowel obstruction or subobstruction, uncontrolled
Crohn's disease or ulcerative colitis

- Current history of chronic diarrhea

- Peripheral neuropathy

- Other serious illness or medical conditions (including contraindication to 5 FU e.g.:
angor, myocardial infarction within 6 months, contraindications to monoclonal

- 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:

- Concomitant (or within 4 weeks before randomisation) administration of any other
experimental drug under investigation

- Concurrent treatment with any other anti-cancer therapy


- Pregnant or breast feeding women

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Per Pfeiffer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Odense University Hospital, Odense, Denmark


Denmark: Danish Medicines Agency

Study ID:

Nordic 7.5



Start Date:

April 2008

Completion Date:

January 2011

Related Keywords:

  • Metastatic Colorectal Cancer
  • Erbitux
  • Colorectal cancer
  • Oxaliplatin
  • Flox
  • Fluorouracil + folinic acid
  • K-RAS
  • Colorectal Neoplasms