Phase I Clinical Study of Liposomal Paclitaxel Plus Capecitabine in Chinese Patients With Advanced Gastric Carcinoma
Inclusion Criteria:
- Age: 18 to 75
- Histologically or cytologically documented gastric adenocarcinoma and
esophagus-gastro adenocarcinoma of metastatic or advanced stages with/without
measurable tumor according to RECIST standard
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Patients who are expected to live at least 3 months
- No prior systemic chemotherapy with advanced stereo- tumor before the
recruitment(recidivist/ metastatic without perioperative chemotherapy at least 6m)
- No Previous anaphylactic reaction to hormone
- Obtaining informed consent
- Patients may comply with the study protocol
- Laboratory tests: Absolute neutrophil count (ANC) ≥2,000/mm³, Platelet count
≥100,000/mm³, Hemoglobin ≥9.0 g/dL, Serum creatinine≤1.5 x the institutional upper
limit of normal (ULN), Creatinine clearance≥50ml/min,Total bilirubin≤1.5 x the
institutional upper limit of normal (ULN), Alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) ≤1.5 x ULN. In the case of known liver metastasis,
ALT and AST(SGOT) ≤1.5 x ULN.
Exclusion Criteria:
- Active uncontrolled central nervous system metastasis
- No adequate organ function or known disease :
- myocardial infarction
- active heart disease
- neuropathy or mental diseases including dementia or epilepsy
- blind、deaf、dumb or extremity disability
- known infection
- active diffuse intravascular coagulation
- known infection with hepatitis virus
- Pregnant or nursing,fertile patients would not use effective contraception during
study treatment
- Prior clinically significant gastrointestinal tract disease , that would influence
obviously capecitabine to absorb,including the ability to swallow by the attending
physician
- No other active malignancies except that in complete remission with squamous cell
carcinoma in situ of the cervix or anus, completely resected basal cell carcinoma, or
no recrudescence for at least 2 year from the time a response was first documented
- Having other study medication within 4w
- Having radiation therapy or operation within 4w
- Any non-remission toxicity ≥ CTC 1 in prior anticancer therapy(including radiation
therapy) (except alopecie and hemoglobin)
- Peripheral nerve disease ≥ 2
- Previous anaphylactic reaction to Capecitabine and Paclitaxel or diluents bases
- Absence of dihydropyrimidine dehydrogenase
- Patients not suitable determined by the attending physician.