TY - JOUR
T1 - Phase i trial of docetaxel, oxaliplatin, and capecitabine (DOC) in untreated gastric cancer patients
AU - Frustaci, Sergio
AU - Buonadonna, Angela
AU - Turchet, Elisa
AU - Corona, Giuseppe
AU - Tabaro, Gianna
AU - Miolo, Gianmaria
AU - Torrisi, Elena
AU - Lo Re, Giovanni
AU - Tumolo, Salvatore
AU - Toffoli, Giuseppe
PY - 2013/6
Y1 - 2013/6
N2 - Background: A combination of docetaxel (D), oxaliplatin (O), and capecitabine (C) (DOC) was studied in this dose-escalation phase Ib trial in patients with untreated advanced gastric cancer. Methods: Dose-limiting toxicity (DLT) included any grade 4 hematological or any grade 3 non-hematological toxicity, besides alopecia and nausea or vomiting. Cohorts of three patients, expanded to six if one DLT occurred, were studied. Two DLTs out of three patients, or ≥3 out of six patients defined the toxic level. The preceding level, maximum tolerated dose (MTD), was further expanded to nine patients. The primary objective was to establish the MTD of the DOC regimen. Results: Twenty-one patients entered four dose levels. Levels I, II, and IIb were considered safe and included 3, 6, and 6 patients, respectively. Level III defined our toxic level with three analyzed patients. Therefore, level IIB was expanded to 9 patients. No other DLTs were recorded. Conclusions: Fractionation of doses and the use of less toxic and more convenient derivatives are the rationales for this new combination. The MTD (mg/m2) was: D, 30 and O, 70, both on days 1 and 8, i.v.; C 1000 per day, days 2-15, p.o.; all given every 3 weeks. A cooperative phase II study has been opened.
AB - Background: A combination of docetaxel (D), oxaliplatin (O), and capecitabine (C) (DOC) was studied in this dose-escalation phase Ib trial in patients with untreated advanced gastric cancer. Methods: Dose-limiting toxicity (DLT) included any grade 4 hematological or any grade 3 non-hematological toxicity, besides alopecia and nausea or vomiting. Cohorts of three patients, expanded to six if one DLT occurred, were studied. Two DLTs out of three patients, or ≥3 out of six patients defined the toxic level. The preceding level, maximum tolerated dose (MTD), was further expanded to nine patients. The primary objective was to establish the MTD of the DOC regimen. Results: Twenty-one patients entered four dose levels. Levels I, II, and IIb were considered safe and included 3, 6, and 6 patients, respectively. Level III defined our toxic level with three analyzed patients. Therefore, level IIB was expanded to 9 patients. No other DLTs were recorded. Conclusions: Fractionation of doses and the use of less toxic and more convenient derivatives are the rationales for this new combination. The MTD (mg/m2) was: D, 30 and O, 70, both on days 1 and 8, i.v.; C 1000 per day, days 2-15, p.o.; all given every 3 weeks. A cooperative phase II study has been opened.
KW - Chemotherapy
KW - DOC regimen
KW - Pharmacokinetic
KW - Phase I
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U2 - 10.1007/s10147-012-0410-z
DO - 10.1007/s10147-012-0410-z
M3 - Article
C2 - 22669361
AN - SCOPUS:84879418486
VL - 18
SP - 510
EP - 516
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
SN - 1341-9625
IS - 3
ER -