FLOX + Erbitux. 1. line treatment to patients with metastatic colorectal cancer and wild type K-RAS tumor. A phase II study. - Nordic 7.5

• Conditions: Patients with metastatic colorectal cancer; MedDRA version: 9.1Level: LLTClassification code 10061451Term: Colorectal cancer

• Registration Number: EUCTR2007-007834-21-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-27
• Last Update Posted: 11 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 86

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 diarrhoea
• 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified