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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00660582
Other study ID # Nordic 7.5
Secondary ID
Status Completed
Phase Phase 2
First received April 11, 2008
Last updated January 20, 2015
Start date April 2008
Est. completion date February 2013

Study information

Verified date January 2015
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor (EGFR). The combination of FLOX and weekly Erbitux has been investigated in the Nordic VII study where 571 patients were randomized to FLOX (regime A) or FLOX + Erbitux (regime B or C). Effect-data has not yet been published but the combination is well tolerated, and other studies have shown that Erbitux administered with chemotherapy seem to be more efficient than chemotherapy alone.

The main purpose with this study is to investigate the effect of FLOX and Erbitux given every second week as first line treatment for patients with metastatic colorectal cancer and K-RAS wildtype tumor.

The latest accessible data regarding treatment towards EGFR and K-RAS mutations shows that patients with K-RAS wildtype responds better to treatment than patients with K-RAS mutations.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date February 2013
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Other:

- 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 antibodies)

- 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

Other:

- Pregnant or breast feeding women

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Cetuximab (Erbitux)
500 mg/m² every second week, intravenous infusion, 8 cycles
Oxaliplatin (Eloxatin) + Fluorouracil + folinic acid
Given in combination day 1 and 2, every second week, 8 cycles

Locations

Country Name City State
Denmark Department of Oncology, Aalborg University Hospital Aalborg
Denmark Department of Oncology, Herlev University Hospital Herlev
Denmark Department of Oncology, Odense University Hospital Odense
Norway Department of Oncology, Haukeland University Hospital Bergen
Norway Kreftsenteret, Ullevaal University Hospital Oslo
Sweden Section of Oncology, Uppsala University Hospital Uppsala

Sponsors (2)

Lead Sponsor Collaborator
Per Pfeiffer Odense University Hospital

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

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