Phase I - II study to assess the feasibility and activity of the triple combination of 5-fluorouracil/folinic acid, carboplatin and irinotecan (CPT-11) administered by chronomodulated infusion for the treatment of advanced colorectal cancer. Final report of the BE-1603 study.

C Focan, F Kreutz, M-P Graas, L Longrée, D Focan-Henrard, G Demolin, N Moeneclaey

Journal: Pathologie-biologie 2013;61(2):e27-31

PMID: 23102894

Full Text on Elsevier Science View on PubMed

Abstract

Thirty-six metastatic colorectal cancer patients received every 2 weeks, as first- (17) or second-line (19) treatment a combined chronotherapy with CPT-11 (infused at day 1 from 2 to 8 a.m.; peak at 5 a.m.), given with 5FU (700 mg/m(2) per day; days 2-5) and folinic acid (300 mg/m(2) per day; days 2-5) both infused from 10 p.m. to 10 a.m. with a peak at 4 a.m., and carboplatin (40 mg/m(2) per day; days 2-5; infused from 10 a.m. to 10 p.m.; peak at 4 p.m.). The doses of CPT11 could be easily pushed from 120 to 180 mg/m(2) in successive cohorts in the phase I part of the study (11 cases). Twenty-five patients were then treated in the phase II of the trial. The overall toxicity was mild leading to dose-reductions in only 11-13% courses. The tumoral activity was interesting with 81% responses and 94% tumour control. Also prolonged survivals were recorded with 8.8 months of progression free and 15.6 months overall survivals. More prolonged survivals were observed in chemotherapy naive patients. Seven patients (19%) could be reoperated from their residual disease.

Address: Oncology Department, CHC-Clinique Saint-Joseph, rue de Hesbaye 75, 4000 Liège, Belgium. [email protected]

DOI: 10.1016/j.patbio.2010.12.005

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MeSH Terms: Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Carboplatin, Colorectal Neoplasms, Disease Progression, Drug Chronotherapy, Female, Fluorouracil, Humans, Infusions, Intravenous, Irinotecan, Leucovorin, Male, Middle Aged, Treatment Outcome