Status:
COMPLETED
Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Stomach Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Considering synergism between docetaxel (D), capecitabine (X), and oxaliplatin (O) and favourable toxicity profile of oxaliplatin over cisplatin, it is to be expected that combination of docetaxel, ca...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00446290
Start Date
March 1 2006
End Date
October 1 2007
Last Update
January 18 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, South Korea, 138-736