Oxaliplatin, Irinotecan and Capecitabine (OCX) for First-Line Treatment of Advanced/Metastatic Colorectal Cancer: A Phase I Trial (SAKK 41/03)

Autor: Lucas Widmer, Thomas Ruhstaller, Mathew Simcock, R. A. Popescu, Doris Lanz, Roger von Moos, Catrina Uhlmann, Dieter Köberle, Arnaud Roth, Richard Cathomas
Rok vydání: 2010
Předmět:
Male
Oncology
Cancer Research
medicine.medical_specialty
Organoplatinum Compounds
Colorectal cancer
Camptothecin/administration & dosage/adverse effects/analogs & derivatives
Irinotecan
Deoxycytidine
Disease-Free Survival
Capecitabine
health services administration
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Neoplasm Metastasis
neoplasms
Neoplasm Staging
ddc:616
Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives
business.industry
Neoplasm Metastasis/pathology
Hematology
General Medicine
Middle Aged
medicine.disease
digestive system diseases
Oxaliplatin
First line treatment
Antineoplastic Combined Chemotherapy Protocols/adverse effects/ therapeutic use
stomatognathic diseases
Camptothecin
Female
Fluorouracil
Colorectal Neoplasms/ drug therapy/pathology
Colorectal Neoplasms
Fluorouracil/administration & dosage/adverse effects/analogs & derivatives
business
therapeutics
Organoplatinum Compounds/administration & dosage/adverse effects
medicine.drug
Zdroj: Onkologie, Vol. 33, No 6 (2010) pp. 295-299
ISSN: 1423-0240
0378-584X
Popis: 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.
Databáze: OpenAIRE