FLOX + Erbitux, 1a linjens-behandling till patienter med metastaserende kolorektalcancer och wild type K-RAS tumor - Nordic 7.5

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-11
• Study Completion: 2011-05-01
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Histology and staging disease:
• Histologically 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) typologically 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 inclusion 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 Oxaliplatin
• Prior treatment with Cetuximab 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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective to the trial is response rate. ;Secondary Objective: The secondary objectives of the trial is to evaluate and determine progression-free survival, time to failure of treatment strategy, survival, safety and toxicity and secondary surgical curative resection frequency. <br>Further we will determine possible prognostic and predictive factors from tissues and blood samples.;Primary end point(s): Primary endpoint is to evaluate response rate.<br><br>Secondary endpoints are to evaluate and determine progression-free survival, time to failure of treatment strategy, survival, safety and toxicity and secondary surgical curative resection frequency. Further we will determine possible prognostic and predictive factors from tissues and bloodsamples.