A Phase I Study of Docetaxel, Capecitabine and Oxaliplatin (DXO) in Patients With Advanced Stomach Cancer
Inclusion Criteria:
- Histologically confirmed unresectable or metastatic advanced gastric adenocarcinoma
- Completion of adjuvant chemotherapy 6 months before the study, or no previous
chemotherapy (But, patients who received docetaxel, capecitabine, or oxaliplatin as
adjuvant chemotherapy should be excluded.)
- Age 18 to 70 years old
- Eastern Cooperative Oncology Group performance status 0~2
- Adequate bone marrow function: white blood cell counts >4,000/µL, absolute neutrophil
count >2,000/µL, and platelets>100,000/µL
- Adequate renal function: creatinine < 1 x upper normal limit (UNL) or creatinine
clearance 60ml/min
- Adequate hepatic function: bilirubin < 1.5 x UNL, aspartate aminotransferase
(AST)/alanine aminotransferase (ALT) levels < 2.5 x UNL, and alkaline phosphatase < 5
x UNL (except in case of bone metastasis without any liver disease)
- Given written informed consent prior to study-specific screening procedures, with the
understanding that the patient has the right to withdraw from the study at any time,
without prejudice
Exclusion Criteria:
- Contraindication to any drug contained in the chemotherapy regimen
- Other tumor type than adenocarcinoma
- Presence or history of central nervous system (CNS) metastasis
- Gastric outlet or bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy > grade 1
- History of significant neurologic or psychiatric disorders
- History of another malignancy within the last five years except cured basal cell
carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Pregnant or lactating women, women of childbearing potential not employing adequate
contraception. Postmenopausal women must have been amenorrheic for at least 12 months
to be considered of non-childbearing potential
- Sexually active males and females (of childbearing potential) unwilling to practice
conception during the study
- Clinically significant cardiac disease (e.g. severe non-compensated hypertension,
non-compensated heart failure, dilated cardiomyopathy, and coronary heart disease
with ST segment depression in electrocardiogram) or myocardial infarction within the
last 6 months
- Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
- Serious metabolic disease such as severe non-compensated diabetes mellitus
- Serious uncontrolled intercurrent infections, or other serious uncontrolled
concomitant disease
- Positive serology for the human immunodeficiency virus (HIV)