Know Cancer

forgot password

A Phase I Study of Docetaxel, Capecitabine and Oxaliplatin (DXO) in Patients With Advanced Stomach Cancer

Phase 1
18 Years
70 Years
Not Enrolling
Stomach Cancer

Thank you

Trial Information

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximal tolerated dose

Outcome Time Frame:


Safety Issue:


Principal Investigator

Yoon-Koo Kang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

October 2007

Related Keywords:

  • Stomach Cancer
  • To determine maximal tolerated dose of DXO regimen
  • Stomach Neoplasms