Phase I trial of docetaxel, oxaliplatin, and capecitabine (DOC) in untreated gastric cancer patients.
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/m(2)) 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.
Division of Medical Oncology B, National Cancer Institute (CRO), Via Franco Gallini, 2, 33081, Aviano, PN, Italy. sfrustaci@cro.it
Sergio
S
Frustaci
Angela
A
Buonadonna
Elisa
E
Turchet
Giuseppe
G
Corona
Gianna
G
Tabaro
Gianmaria
G
Miolo
Elena
E
Torrisi
Giovanni
G
Lo Re
Salvatore
S
Tumolo
Giuseppe
G
Toffoli
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage*; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage*
D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil