Dose Escalation 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.