Histologically confirmed adenocarcinoma of the colon or the rectum and unresectable metastases or advanced locoregional disease Classification code 10052360
Conditions
Interventions
Trade Name: Vorina®, 350mg/14ml, solution for injection
Product Name: Vorina®, 350mg/14ml, solution for injection
Product Code: 1276 IS 153 F12
Pharmaceutical Form: Solution for injection
INN or Propo
5000mg/100ml solution for injection
Product Code: 1276 IS18 F12
1276 IS110 F12
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 5-Fluorouracil
Other descriptive name: 5-Fluorouracil
Concentration unit: mg/ml milligram(s)/millilitre
Concentration ty
Sponsors
TEVA Pharma Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first objective is to evaluate, in terms of Objective Response Rate (ORR), whether the combined infusional Leucovorin Sodium and 5-FU has the potential of being superior to the standard sequential administration of Leucovorin Calcium and 5-FU, both in combination with standard Irinotecan or Oxaliplatin.;Secondary Objective: The second objective is to explore safety and tolerability of this combined infusional approach.;Primary end point(s): The primary end-point for efficacy is the Objective Response Rate (using RECIST criteria) during the treatment period. | — |
Countries
Belgium
Outcome results
None listed