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)

Randomized Phase II Study 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2012-07-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2012-07-13
• Last updated: 2019-04-11

Locations

1 site across 1 country: Spain