Bevacizumab + Folfox4 or Xelox2 as first- line treatment in colorectal cancer. Randomized phase II study.

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2011
INTERVENTION: Trade Name: AVASTIN*INFUS 1FL 400MG 16ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Bevacizumab Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 5‐ Trade Name: FLUOROURACILE TEVA*IV 5G 100ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Fluorouracil Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 2000‐ Trade Name: ELOXATIN*INFUS 1FL 40ML 5MG/ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Oxaliplatin Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 85‐ Trade Name: XELODA*120CPR RIV 500MG Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Capecitabine Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 1000‐ Trade Name: LEDERFOLIN*INFUS 1FL 100MG Pharmaceutical Form: Powder for infusion INN or Proposed INN: Calcium levofolinate Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 100‐ CONDITION: Oncologic patients ; MedDRA version: 13.1 Level: LLT Classification code 10001167 Term: Adenocarcinoma of colon System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) PRIMARY OUTCOME: Main Objective: To estimate the effectiveness of the combination of Oxaliplatino and Capecitabine (XELOX‐2) + bevacizumab measured in terms of objective response rate in non treaty advanced colorectal cancer treatment. Primary end point(s): To estimate the effectiveness of the combination of Oxaliplatino and Capecitabine (XELOX‐2) + bevacizumab measured in terms of objective response rate in non treaty advanced colorectal cancer treatment. Secondary Objective: 1‐overall survival 2‐Time to progression INCLUSION CRITERIA: ‐Histologically proven diagnosis of colorectal cancer ‐Mutation Status KRAS ‐No previous first line chemoterapy treatment ‐ Written informed consent. 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: 17c18b3f0e918a1e296e27ccdcbcb292be5c5342
First added on: Aug 22, 2024