drugset / Trial / 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)
Phase 2
Completed
240 enrolled
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Roche Pharma AG · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2012-07
- Primary completion
- 2018-11
- Completion
- 2018-11
Publications
- Valladares-Ayerbes M, Toledano-Fonseca M, Grana B, Jimenez-Fonseca P, Pulido-Cortijo G, Gil S, Sastre J, Salud A, Rivera F, Salgado M, Garcia-Alfonso P, Lopez Lopez R, Guillen-Ponce C, Rodriguez-Ariza A, Vieitez JM, Diaz-Rubio E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD). Associations of blood RNA biomarkers and circulating tumour cells in patients with previously untreated metastatic colorectal cancer. BMC Cancer. 2025 Apr 21;25(1):743. doi: 10.1186/s12885-025-14098-9.
- Jimenez-Fonseca P, Sastre J, Garcia-Alfonso P, Gomez-Espana MA, Salud A, Gil S, Rivera F, Reina JJ, Quintero G, Valladares-Ayerbes M, Safont MJ, La Casta A, Robles-Diaz L, Garcia-Paredes B, Lopez Lopez R, Guillot M, Gallego J, Alonso-Orduna V, Diaz-Rubio E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Association of Circulating Tumor Cells and Tumor Molecular Profile With Clinical Outcomes in Patients With Previously Untreated Metastatic Colorectal Cancer: A Pooled Analysis of the Phase III VISNU-1 and Phase II VISNU-2 Randomized Trials. Clin Colorectal Cancer. 2023 Jun;22(2):222-230. doi: 10.1016/j.clcc.2023.02.004. Epub 2023 Feb 21.
- Sastre J, Orden V, Martinez A, Bando I, Balbin M, Bellosillo B, Palanca S, Peligros Gomez MI, Mediero B, Llovet P, Moral VM, Vieitez JM, Garcia-Alfonso P, Calle SG, Ortiz-Morales MJ, Salud A, Quintero G, Lopez C, Diaz-Rubio E, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Association Between Baseline Circulating Tumor Cells, Molecular Tumor Profiling, and Clinical Characteristics in a Large Cohort of Chemo-naive Metastatic Colorectal Cancer Patients Prospectively Collected. Clin Colorectal Cancer. 2020 Sep;19(3):e110-e116. doi: 10.1016/j.clcc.2020.02.014. Epub 2020 Mar 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |