A phase I study of docetaxel, oxaliplatin, & capecitabine (DOC) as first-line therapy of patients with locally advanced or metastatic adenocarcinoma of stomach and GE junction.
OBJECTIVE
We conducted a phase I trial of chemotherapy in patients with advanced gastro-esophageal cancer.


METHODS
Eligible patients had chemotherapy doses increased until dose limiting toxicity (DLT) was observed.


RESULTS
Fourteen patients were accrued. No DLT was observed in first three patients at level 1. DLT was observed in two out of five patients at level 2. Six additional patients were treated at level 1.


CONCLUSIONS
Recommended doses for future trials are: docetaxel 30 mg/m(2) and oxaliplatin 50 mg/m(2) on days 1 and 8 and capecitabine 675 mg/m(2) PO, bid, on days 1-14 on a three weekly basis.
Malik
Imtiaz
I
Loma Linda Oncology Medical Group Inc, Claremont, CA 91711, USA. imalik@llomgi.com
Bernal
Pedro
P
Byrd
Janet
J
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000633:toxicity; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000633:toxicity*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000633:toxicity; D003967:Diarrhea / Q000139:chemically induced; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005221:Fatigue / Q000139:chemically induced; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000633:toxicity; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000633:toxicity; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage / Q000633:toxicity; D014839:Vomiting / Q000139:chemically induced
D000964:Antimetabolites, Antineoplastic; D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil