Phase II randomized study of Combined Infusional Leucovorin Sodium and 5-FU Versus the Classical Sequential administration of Leucovorin Calcium followed by 5-FU both in combination with standard Irinotecan or Oxaliplatin (SFOLFOX/SFOLFIRI vs FOLFOX/FOLFIRI) in patients with metastatic colorectal cancer. - SFOLFOX/SFOLFIRI vs FOLFOX/FOLFIRI

Conditions: Histologically confirmed adenocarcinoma of the colon or the rectum and unresectable metastases or advanced locoregional disease
Classification code 10052360

Registration Number: EUCTR2004-004901-12-BE

Lead Sponsor: TEVA Pharma Belgium

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 113

Inclusion Criteria

- Patient has histological confirmed adenocarcinoma of the colon or rectum
- Patient has unresectable metastases or advanced locoregional disease
- Patient has had no previous chemotherapy (except adjuvant single agent 5-FU if completed at least 6 months prior to randomisation)
- Patient is aged 18 years or more
- The Performance Status (WHO) of patient is 0, 1 or 2
- Patient has a measurable disease according to RECIST criteria
- Patient has at least 1 measurable lesion outside a previously irradiated area or an area treated with physical devices (e.g. cryotherapy, laser or thermo ablation). Previous radiotherapy should be stopped at least 4 weeks prior to randomisation
- Patient has had a clinical evaluation 3 weeks or less prior to randomisation, including:
- Leucocytes = 3,000/mm3
- Platelets = 100,00/mm3
- Adequate renal function: creatinine clearance =51 ml/min calculated according to Cockroft and Gault Formula
- Total bilirubin = 2 x upper normal limits
- ASAT/ALAT = 2.5 x upper normal limits (= 5 ULN in case of liver metastasis)
- Patient gave written informed consent according to ICH/GCP and national/local regulations
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

- Patient had prior treatment with another investigational drug within 4 weeks prior to randomisation
- Patient has symptomatic CNS metastases
- Patient has a second malignancy, except adequately treated in situ carcinoma of the cervix or non-melanoma skin cancer
- Patient has a severe cardiac disease including uncontrolled angina pectoris and myocardial infarction within 6 months
- Patient has active Crohn’s disease
- Patient has another uncontrolled severe medical condition
- Patient (if female) is pregnant or breast feeding or patient (male or female) is fertile without adequate contraception
- Patient has a psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial