| Title: |
Capecitabine and oxaliplatin in advanced colorectal cancer: A dose-finding study |
| Authors: |
Zeuli, M.; Di Costanzo, F.; Sdrobolini, A.; Gasperoni, S.; Paoloni, F. P.; Carpi, A.; Moscetti, L.; Cherubini, R.; Cognetti, F.; on behalf of Gruppo Oncologico Italiano per la Ricerca Clinica (GOIRC) and Gruppo Oncologico Laziale (GOL) |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2001 |
| Collection: |
HighWire Press (Stanford University) |
| Subject Terms: |
Original articles |
| Description: |
Purpose : Capecitabine and oxaliplatin are both active anti-cancer agents in the treatment of patients with advanced colorectal cancer (ACRC). The aim of this dose-finding trial was to determine the maximum-tolerated dose (MTD), the dose-limiting toxicities (DLTs) and the activity of the combination in patients with advanced colorectal cancer. Patients and methods : Twenty-five chemotherapy-pretreated patients received the combination of capecitabine and oxaliplatin. Capecitabine was administered orally twice a day continuously for 14 days in doses ranging from 1650 to 2500 mg/m2/d, and oxaliplatin was administered as a two-hour infusion on day 1 using dose, ranges from 100 to 130 mg/m2 repeated every three weeks. Results : Twenty-five patients were assessable for toxicity, and DLTs were diarrhea (grade ≥ 3: 27%) and stomatitis (grade ≥3: 9%) at dose level VI. Dose level V (capecitabine 2500 mg/m2 and oxaliplatin 120 mg/m2) was found to be the MTD. Hematological toxicity was minimal, overall neuro-toxicity (grade 1–4) was 27% with 1% grade 3–4. A global response rate was 17% (95% confidence interval (95% Cl): 2%–32%) and the median overall survival was 12 months. Conclusion : The recommended dose for further phase II studies is capecitabine 2500 mg/m2/d with intermittent schedule and oxaliplatin 120 mg/m2 every three weeks. The toxicities were mainly gastrointestinal: diarrhea, stomatitis and vomiting. This combination should be studied in phase II trials in advanced colorectal. |
| Document Type: |
text |
| File Description: |
text/html |
| Language: |
English |
| Relation: |
http://annonc.oxfordjournals.org/cgi/content/short/12/12/1737; http://dx.doi.org/10.1023/A:1013562914125 |
| DOI: |
10.1023/A:1013562914125 |
| Availability: |
http://annonc.oxfordjournals.org/cgi/content/short/12/12/1737; https://doi.org/10.1023/A:1013562914125 |
| Rights: |
Copyright (C) 2001, European Society for Medical Oncology |
| Accession Number: |
edsbas.24AF4E87 |
| Database: |
BASE |