Selecting Treatment in Colorectal Cancer:Capecitabine or 5-fluorouracil Selection to be Combined With Oxaliplatin or Irinotecan as First-line Chemotherapy in Advanced Colorectal Cancer

Phase 2 Completed 195 enrolled Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) Hoffmann-La Roche · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate the efficacy and safety of the capecitabine or 5-fluorouracil selection, according to polymorphisms in TS-3'UTR and ERCC1-118, to be combined with oxaliplatin or irinotecan as first-line chemotherapy in advanced colorectal cancer

Timeline

Start: 2010-02
Primary completion: 2013-11
Completion: 2013-11

Outcome

Missed primary endpoint

paper The primary objective was not met: median PFS was 9.4 months in the control group and 10.1 months in the experimental group (P = 0.745). PMID 29145602 ↗

Publications

Abad A, Martinez-Balibrea E, Vieitez JM, Alonso-Orduna V, Garcia Alfonso P, Manzano JL, Massuti B, Benavides M, Carrato A, Zanui M, Gallego J, Gravalos C, Conde V, Provencio M, Valladares-Ayerbes M, Salazar R, Sastre J, Montagut C, Rivera F, Aranda E. Genotype-based selection of treatment of patients with advanced colorectal cancer (SETICC): a pharmacogenetic-based randomized phase II trial. Ann Oncol. 2018 Feb 1;29(2):439-444. doi: 10.1093/annonc/mdx737.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	5 mg/kg	—
Subject	Bevacizumab	Monoclonal antibody	7.5 mg/kg	—
Subject	Capecitabine	Small molecule	800 mg/m2	—
Subject	Capecitabine	Small molecule	1000 mg/m2	—
Subject	Irinotecan	Small molecule	80 mg/m2	—
Subject	Irinotecan	Small molecule	200 mg/m2	—
Subject	Oxaliplatin	Small molecule	85 mg/m2	—
Subject	Oxaliplatin	Small molecule	130 mg/m2	—
Subject	fluorouracil	Small molecule	2250 mg/m2	—