Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Neoplastic Cells, Circulating

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasm Metastasis

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Bevacizumab

Irinotecan

Cetuximab

Leucovorin

Fluorouracil

Oxaliplatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

* 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 + bevacizumab

* 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).

FOLFIRI + cetuximab

Eduardo Díaz-Rubio, MD-PhD

Enrique Aranda, MD-PhD

Javier Sastre, MD-PhD

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

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

Roche Pharma AG

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)	NCT01640444	Colorectal Canc...	FOLFIRI + bevac... FOLFIRI + cetux...	18 Years - 70 Years	Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
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)	NCT01640444	Colorectal Canc...	FOLFIRI + bevac... FOLFIRI + cetux...	18 Years - 70 Years	Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Spots Global Cancer Trial Database for braf and pik3k