BACKGROUND: A phase I/II study was performed to determine the safety and activity of a capecitabine plus oxaliplatin and irinotecan (COI) regimen using capecitabine concurrently with oxaliplatin and irinotecan in previously untreated patients with metastatic colorectal cancer. PATIENTS AND METHODS: Patients received irinotecan on day 1, oxaliplatin (85 mg/m(2)) on day 2 and capecitabine (1000 mg/m(2) orally twice daily) on days 2-6 of a biweekly schedule. Three dose levels ranging from 150 to 180 mg/m(2) were explored for irinotecan in sequential cohorts of three to six patients. Once the recommended dose was determined, a total of 28 eligible patients were planned at this dose level. RESULTS: Thirty-eight patients received a median of six cycles. The recommended phase II dose of irinotecan was 180 mg/m(2). Toxicity was manageable: the most common severe toxicities were diarrhoea (24%) and nausea (16%). Of 27 assessable patients treated at the recommended dose, 17 achieved a partial response (overall response rate (ORR) 63%; 95% confidece interval (CI), 44 to 78%), with eight patients undergoing liver metastasectomy. Estimated progression-free survival and overall median survival were 8.5 and 23.5 months, respectively. CONCLUSIONS: Biweekly COI is feasible and active. Tolerability and ease of administration make the regimen well suited for downsizing hepatic colorectal metastases before curative surgery.
BACKGROUND: A phase I/II study was performed to determine the safety and activity of a capecitabine plus oxaliplatin and irinotecan (COI) regimen using capecitabine concurrently with oxaliplatin and irinotecan in previously untreated patients with metastatic colorectal cancer. PATIENTS AND METHODS: Patients received irinotecan on day 1, oxaliplatin (85 mg/m(2)) on day 2 and capecitabine (1000 mg/m(2) orally twice daily) on days 2-6 of a biweekly schedule. Three dose levels ranging from 150 to 180 mg/m(2) were explored for irinotecan in sequential cohorts of three to six patients. Once the recommended dose was determined, a total of 28 eligible patients were planned at this dose level. RESULTS: Thirty-eight patients received a median of six cycles. The recommended phase II dose of irinotecan was 180 mg/m(2). Toxicity was manageable: the most common severe toxicities were diarrhoea (24%) and nausea (16%). Of 27 assessable patients treated at the recommended dose, 17 achieved a partial response (overall response rate (ORR) 63%; 95% confidece interval (CI), 44 to 78%), with eight patients undergoing liver metastasectomy. Estimated progression-free survival and overall median survival were 8.5 and 23.5 months, respectively. CONCLUSIONS: Biweekly COI is feasible and active. Tolerability and ease of administration make the regimen well suited for downsizing hepatic colorectal metastases before curative surgery.
Authors: Sun Young Kim; Yong Sang Hong; Byung Chang Kim; Ji Won Park; Hyo Seong Choi; Seung-Yong Jeong; Dae Yong Kim; Chang Won Hong; Dae Kyung Sohn; Kyung Hae Jung Journal: Invest New Drugs Date: 2008-09-25 Impact factor: 3.850
Authors: R Zarate; J Rodríguez; E Bandres; A Patiño-Garcia; M Ponz-Sarvise; A Viudez; N Ramirez; N Bitarte; A Chopitea; J Gacía-Foncillas Journal: Br J Cancer Date: 2010-03-09 Impact factor: 7.640
Authors: Alexander Stein; Gabriel Glockzin; Andreas Wienke; Dirk Arnold; Thomas Edelmann; Bert Hildebrandt; Stephan Hollerbach; Gerald Illerhaus; Alfred Königsrainer; Michael Richter; Hans J Schlitt; Hans-Joachim Schmoll Journal: BMC Cancer Date: 2012-08-16 Impact factor: 4.430
Authors: E Vasile; G Masi; L Fornaro; S Cupini; F Loupakis; S Bursi; I Petrini; S Di Donato; I M Brunetti; S Ricci; A Antonuzzo; S Chiara; D Amoroso; M Andreuccetti; A Falcone Journal: Br J Cancer Date: 2009-05-12 Impact factor: 7.640
Authors: H Y Sheikh; J W Valle; T Waddell; K Palmer; G Wilson; A Sjursen; O Craven; R Swindell; M P Saunders Journal: Br J Cancer Date: 2008-08-19 Impact factor: 7.640