Open-label randomized, parallel group, phase III, multicenter trial comparing two different sequences of therapy (irinotecan/cetuximab followed by fluorouracil/leucovorin with oxaliplatin (FOLFOX-4) vs. FOLFOX-4 followed by irinotecan/cetuximab) in metastatic colorectal patients treated with fluorouracil/leucovorin with irinotecan (FOLFIRI)/bevacizumab as first line chemotherapy

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: Trade Name: OXALIPLATINO MAY*INF FL 100MG Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Oxaliplatin Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 85‐ Trade Name: IRINOTECAN MAYNE*INF 100MG 5ML Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Irinotecan Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 20‐ Trade Name: ERBITUX*INFUS 1FL 50ML 2MG/ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cetuximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ CONDITION: Patients with histologically confirmed metastatic colorectal cancer progressed after a first line treatment containing FOLFIRI and BEV. ; MedDRA version: 9.1 Level: LLT Classification code 10061045 Term: Colon neoplasm PRIMARY OUTCOME: Main Objective: overall survival Primary end point(s): ACTIVITY; TOXICITY; QUALITY of LIFE Secondary Objective:  Progression free survival;  Quality of life, evaluated by means a VAS scale;  Health resource utilisation and economic evaluation;  Toxicity and incidence of adverse events INCLUSION CRITERIA:  Age >18 < 75 years of age  Diagnosis of histologically proven adenocarcinoma of the colon or rectum, stage IV  ECOG performance status 0‐1 at study entry  Neutrophils ≥ 1.5 x 109 /uL, platelets ≥ 100 x 109/uL, and hemoglobin ≥ 9 g/dL  Bilirubin level either normal or < 1.5 x ULN  ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)  Serum creatinine < 1.5 x ULN  Effective contraception for both male and female patients if the risk of conception exists  Life expectancy of ≥ 3 months  Signed written informed consents 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
Epistemonikos ID: fc4a27131c2ae7a51d38af3d1c65a172a2933a54
First added on: Aug 21, 2024