ADVANCED COLO-RECTAL TUMOUR MedDRA version: 9.1 Level: LLT Classification code 10010029 Term: Colorectal cancer NOS
Conditions
Interventions
Trade Name: ELOXATIN*IV 1FL POLV 100MG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Oxaliplatin
CAS Number: 61825-94-3
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
OSPEDALE ONCOLOGICO DI BARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. LOCALLY ADVANCED OR METASTATIC UNRESECTABLE COLO-RECTAL CARCINOMA 2. IMMUNOHISTOCHEMICAL EVIDENCE OF EGFR EXPRESSION IN THE PRIMITIVE TUMOUR AND/OR IN A METASTASIS AT LEAST 3. PRESENCE OF A MEASURABLE LESION AT LEAST 4. AGE BETWEEN 18 AND 75 YEARS OLD 5. LIFE EXPECTANCY >= 3MONTHS 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: 1. BRAIN METASTASIS 2. PREVIOUS CHEMOTHERAPY 3. PREVIOUS EXPOSURE TO EGF, MONOCLONAL ANTIBODIES, INHIBITORS OF THE TRANSDUCTION SIGNAL OR THERAPY HAVING THE EGFR AS A TARGET 4. PERIFERIC NEUROPATY 5. ALLERGIC REACTIONS TO THE COMPONENTS OF THE TREATMENT 6. PREGNANCY AND BREAST-FEEDING 7. OTHER TUMOURS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PERCENTAGE OF OBJECTIVE RESPONSES;Primary end point(s): TO ESTIMATE THE PERCENTAGE OF OBJECTIVE RESPONSES;Secondary Objective: 1. TOXICITY OF THE COMBINATION 2. AVERAGE TIME FOR THE FAILURE OF THE TREATMENT 3. AVERAGE TIME TO PROGRESSION 4. TOTAL SURVIVAL 5. PERCENTAGE OF RESECTIONS OF THE LIVER/LUNG METASTASIS AFTER THE TREATMENT 6. CORRELATION BETWEEN THE EXPRESSION LEVELS OF THE EGF RECEPTOR AND THE OBJECTIVE RESPONSES 7. CORRELATION BETWEEN SKIN TOXICITY AND THE OBJECTIVE RESPONSES | — |
Countries
Italy
Outcome results
None listed