Efficacy of Chemotherapy, Associated to Either Cetuximab or Bevacizumab, in KRAS Wild-type Metastatic Colorectal Cancer Patients With Progressive Disease After Receiving First-line Treatment With Bevacizumab

Sponsor
UNICANCER
Study ID
NCT01442649
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    85mg/m² over 120 mn on D1 every 2 weeks up to progression or toxicity
  • Folinic Acid — DRUG
    400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1 (in the same time that oxaliplatin or irinotecan) every 2 weeks up to progression or toxicity
  • 5-fluoro-uracil — DRUG
    400mg/m² in bolus on D1, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity
  • Irinotecan — DRUG
    180 mg/m2 over 90 mn IV on D1 every 2 weeks up to progression or toxicity
  • Bevacizumab — DRUG
    5 mg/kg IV over 90 mn on D1 every 2 weeks up to progression or toxicity
  • Cetuximab — DRUG
    500mg/m² on D1 every 2 weeks up to progression or toxicity

Study Details

The main objective is to evaluate progression-free survival (PFS) at 4 months. The secondary objectives are to evaluate the objective response rate (OR) (= complete responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the progression-free survival (PFS), the overall survival (OS), the overall survival from the date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the quality of life according to the EORTC QLQ-C30 criteria. The objectives of the biological study are to evaluate potentially predictive anti-EGFR and anti-VEGF response factors and CEC rates as predictive biomarkers for the efficacy of bevacizumab associated with chemotherapy in mCRC treatment.

Key Dates

Start date
Dec 31, 2010
Status verified
Jan 2022
Primary completion
Oct 31, 2015
Completion
Dec 31, 2017

Study Design

Enrollment
133 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A : bevacizumab + fluoropyrimidine-based chemotherapy
    Every 2 weeks : \- mFOLFOX6 : Oxaliplatin 85 mg/m2 over 120 mn IV on D1, Folinic Acide 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h. OR \- FOLFIRI : Irinotecan 180 mg/m2 en 90 mn IV on day D1, Folinic acid 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h. AND Bevacizumab 5 mg/kg IV every 2 weeks.
  • Experimental: Arm B : cetuximab + fluoropyrimidine-based chemotherapy
    Every 2 weeks : \- mFOLFOX6 : Oxaliplatin 85 mg/m2 over 120 mn IV on D1, Folinic Acide 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h. OR \- FOLFIRI : Irinotecan 180 mg/m2 en 90 mn IV on day D1, Folinic acid 400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1, 5-fluoro-uracil 400 mg/m² in bolus IV on D1 and 5-fluoro-uracil 2400 mg/m² in infusion IV over 46 h. AND Cetuximab : 500 mg/m² IV every 2 weeks

Primary Outcome Measure

Progression-free survival (PFS) at 4 months [ Time Frame: 4 months ]

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