A phase I/II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer.
OBJECTIVE
We designed this phase I/II study of docetaxel-oxaliplatin combination chemotherapy to determine the dose-limiting toxicity (DLT), maximum tolerated dose and efficacy as a first-line treatment in patients with advanced gastric cancer.


METHODS
Patients with histologically proven, chemo-naive gastric adenocarcinoma were eligible. For the phase I part, three dose levels of oxaliplatin and docetaxel every 3 weeks were tested in a cohort of three patients for each level (respectively, 100 and 60 mg/m(2), 100 and 75 mg/m(2), 130 and 75 mg/m(2)). Patients were treated up to a maximum of nine cycles of oxaliplatin and docetaxel unless there was documented disease progression, an unacceptable adverse event, or withdrawal of consent.


RESULTS
No DLT was observed at any of the three levels tested in the phase I portion. Therefore, oxaliplatin 130 mg/m(2) and docetaxel 75 mg/m(2) were recommended for the phase II study. All 47 patients were evaluable for toxicity and treatment response. The overall response rate was 55.3% (95% CI, 40.6-70.1%) and median duration of response was 4.2 months (range 0.9-9.5 months). After a median follow-up duration of 13.3 months, median overall survival was 12.7 months (95% CI: 10.4-14.9). The median time to progression was 5.0 months (95% CI, 3.4-6.5 months). The main toxicities (grade 3 or 4) were febrile neutropenia (14.9%), neutropenia (23.4%), diarrhea (10.6%) and neurotoxicity (8.5%).


CONCLUSIONS
The combination of docetaxel and oxaliplatin was feasible with favorable toxicity profile and showed a promising anti-tumor activity in unresectable, metastatic gastric cancer patients.
Kim
Kyoung Ha
KH
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-dong Kangnam-gu, Seoul, 135-710, South Korea.
Park
Young Suk
YS
Chang
Myung Hee
MH
Kim
Hyo Song
HS
Jun
Hyun Jung
HJ
Uhm
Jieun
J
Yi
Seong Yoon
SY
Lim
Do Hyoung
DH
Ji
Sang Hoon
SH
Park
Min Jae
MJ
Lee
Jeeyun
J
Park
Se Hoon
SH
Park
Joon Oh
JO
Lim
Ho Yeong
HY
Kang
Won Ki
WK
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077143:Docetaxel; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel