Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma

Phase Ⅱ Study of Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma

The primary objective of this study is to evaluate PFS of gemcitabine,vincristine and cisplatin as second line therapy in patients with sarcoma. 40 patients will be treated into this study.

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