Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments

Inclusion Criteria:

• patient willing to sign an Investigational Review Board(IRB) approved written informed consent document
• patient age: 18 years -75years
• patient must have histologically confirmed solid tumor
• patient must have uncurable and unresectable solid tumor of advanced stages
• patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• patient must have a life expectancy at least 12 weeks
• patient must have at least one lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
• patient must have progress or recurrence after at least one chemotherapy regimen for advanced stage
• patient must have adequate marrow,hepatic and renal function: defined as ANC≥2.0 × 109/L，PLT ≥10 ×109/dL, Hb ≥ 9g/dL;GOT/GPT≤2.5×ULN；Toltle bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN or Creatinine clearance≥40ml/min(according to Cockcroft-Gault；
• patient must have the left ventricular ejection fraction (LVEF)≥50% confirmed by ultrasonic heart scanning
• women must have the negative pregnancy test; women and men must agree to use adequate contraception

Exclusion Criteria:

• patient must non have received any other antitumor therapy, including chemotherapy, radiotherapy, hormonal therapy, biological therapy, immunotherapy and any other investigational agent within 4 weeks prior to starting study
• patient must non have any pre-existing toxity from prior antitumor therapy (any≥ grade 2, any≥1 peripheral neuropathy, excluding alopecia)
• patient must non have uncontrolled cerebral metastases
• patient must non have any uncontrolled heart illness including, but not limited to, ongoing symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, arterial hypertension (≥180/110), heart failure and myocardial infarction within 6 months prior to starting study
• Patient must not have a history of a malignancy tumor except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix for at least 5 years
• patient must non have any serious illness including, but not limited to hepatic, renal, respiratory and uncontrolled diabetes mellitus
• patient must non have psychiatric illness/social situations that would limit compliance with study requirements.
• patient must non have active or uncontrolled infection including, but not limited to tuberculosis,HIV,HBV, HCV
• Patient must non be receiving any other antitumor agent
• patient must non be pregnant and/or breastfeeding
• patient must non be receiving protease inhibitors,inhibitors of CYP3A4,antifungal agents and inducing agent of CYP3A4