Influence of BRAF and PIK3K Status on the Efficacy of 5-Fluorouracil/Leucovorin/Oxaliplatin (FOLFIRI) Plus Bevacizumab or Cetuximab in Patients With RAS Wild-type Metastatic Colorectal Carcinoma and < 3 Circulating Tumor Cells (CTC)

Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study ID
NCT01640444
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • FOLFIRI + bevacizumab — DRUG
    * Bevacizumab 5 mg/kg iv, followed by * Irinotecan 180 mg/m2 iv administered over a period of 30-90 minutes, followed by * Leucovorin (LV) 400 mg/m2 iv administered over a period of 2 hours, followed by * 5-FU 400 mg/m2 iv bolus, followed by * 5-FU 2,400 mg/m2 for 46 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle).
  • FOLFIRI + cetuximab — DRUG
    * Cetuximab in an initial 120-minute infusion on day 1 of 400 mg/m2, followed by 60-minute infusions of cetuximab at a dose of 250 mg/m2, once weekly * FOLFIRI: * Irinotecan 180 mg/m2 iv administered over a period of 30-90 minutes, followed by * Leucovorin (LV) 400 mg/m2 iv administered over a period of 2 hours, followed by * 5-FU 400 mg/m2 iv bolus, followed by * 5-FU 2,400 mg/m2 for 46 h continuous infusion FOLFIRI will be given after the cetuximab infusion on day 1 of each period (every 2 weeks: 1 cycle).

Study Details

The purpose of the study is to explore the influence of BRAF and PIK3K status on the efficacy of FOLFIRI plus Bevacizumab or Cetuximab, as first line therapy of patients with RAS wild-type metastatic colorectal carcinoma and \< 3 circulating tumor cells

Key Dates

First listed
Jul 13, 2012
Start date
Jul 31, 2012
Status verified
Aug 2018
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018

Study Design

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

Arms

  • Experimental: A
    FOLFIRI+bevacizumab
  • Experimental: B
    FOLFIRI + cetuximab

Primary Outcome Measure

progression free survival (PFS) [ Time Frame: 5 years ]

Related Studies