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)

PHASE2CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

November 30, 2018

Study Completion Date

November 30, 2018

Conditions
Colorectal Cancer Metastatic
Interventions
DRUG

FOLFIRI + bevacizumab

"* 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)."

DRUG

FOLFIRI + cetuximab

"* 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)."

Trial Locations (1)

28046

Spanish Cooperative Group for Digestive Tumour Therapy, Madrid

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER

NCT01640444 - 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) | Biotech Hunter | Biotech Hunter