Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer

Launched by ASAN MEDICAL CENTER · Mar 9, 2007

Keywords

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Eligibility criteria

• 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)