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Title

Oxaliplatin, irinotecan and capecitabine (OCX) for first-line treatment of advanced/metastatic colorectal cancer: a phase I trial (SAKK 41/03)

Authors
von Moos, Roger
Ruhstaller, Thomas
Widmer, Lucas
Uhlmann, Catrina
Cathomas, Richard
Koberle, Dieter
Simcock, Mathew
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Published in Onkologie. 2010, vol. 33, no. 6, p. 295-299
Abstract BACKGROUND: A phase I multicentre trial was conducted to define the recommended dose of capecitabine in combination with oxaliplatin and irinotecan (OCX) in metastatic colorectal cancer. PATIENTS AND METHODS: Patients with performance status (PS) < 2 and adequate haematological, renal and liver function received oxaliplatin 70 mg/m(2) on days 1 and 15, irinotecan 100 mg/m(2) on days 8 and 22 and one of five dose levels (DL 1-5, between 800 and 1,600 mg/ m(2)) of capecitabine on days 1-29 every 5 weeks. RESULTS: 23 patients received a median of 3 cycles. 3 dose-limiting toxicities occurred (DL 1: grade 3 (G3) elevated alkaline phosphatase; DL 5: 1 patient G4 hyperglycaemia/G3 diarrhoea and 1 sudden death). The most common severe adverse event was G3 diarrhoea (13%). Severe haematotoxicity was rare. Therapy was stopped mainly due to metastasectomy or tumour progression (7 patients each). 8 patients reached a partial response. Median time to progression and overall survival (OS) were 8.0 and 21.9 months, respectively. CONCLUSIONS: The recommended capecitabine dose in this schedule is 1,400 mg/m(2) daily. The OCX regimen is well tolerated. The response rate was surprisingly low with progression-free survival (PFS) and OS within the range of a triple combination. Further studies in combination with targeted agents are warranted.
Keywords Antineoplastic Combined Chemotherapy Protocols/adverse effects/ therapeutic useCamptothecin/administration & dosage/adverse effects/analogs & derivativesColorectal Neoplasms/ drug therapy/pathologyDeoxycytidine/administration & dosage/adverse effects/analogs & derivativesDisease-Free SurvivalFemaleFluorouracil/administration & dosage/adverse effects/analogs & derivativesHumansMaleMiddle AgedNeoplasm Metastasis/pathologyNeoplasm StagingOrganoplatinum Compounds/administration & dosage/adverse effects
Identifiers
PMID: 20523092
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Research group Groupe Roth Arnaud (oncologie) (285)
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VON MOOS, Roger et al. Oxaliplatin, irinotecan and capecitabine (OCX) for first-line treatment of advanced/metastatic colorectal cancer: a phase I trial (SAKK 41/03). In: Onkologie, 2010, vol. 33, n° 6, p. 295-299. https://archive-ouverte.unige.ch/unige:21379

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Deposited on : 2012-05-23

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