Phase Ⅱ Study of Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
Inclusion Criteria:
- Give written informed consent prior to study, with understanding that the patient has
the right to withdraw from the study at any time without prejudice
- Be female of male and ≥18 and ≤75 years of age
- Be ambulatory and have ECOG performance status of ≤1
- Have histological confirmed sarcoma
- Locally advanced or metastatic sarcoma who receive first-line chemotherapy.
- Have at least one target lesion according to the RECIST criteria.
Exclusion Criteria:
- Pregnant or lactating women
- patient has received chemotherapy drugs including gemcitabine,vincristine and
cisplatin
- Chemotherapy within four weeks preceding treatment start
- ECOG ≥ 2
- Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start
or insufficient recovery from the effects of prior radiotherapy
- Participation in any investigational drug study within 4 weeks preceding treatment
start
- History of another malignancy within the last five years except cured basal cell
carcinoma of skin and carcinoma in-situ of uterine cervix .Abnormal laboratory
values: hemoglobin < 8. 0g/dl, neutrophil< 1.5×109/L, platelet< 100×109/L.
- serum creatine > upper limit of normal (ULN)
- serum bilirubin > ULN
- alanine aminotransferase(ALT) and aspartate aminotransferase(AST)>5×ULN
- alkaline phosphatase(AKP)>5×ULN
- Serious uncontrolled intercurrence infection
- Life expectancy of less than 3 months