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

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Sarcoma

Chemotherapy

Treatments

Drug: GVP

Study type

Interventional

Funder types

Other

Identifiers

NCT01192633

GVP-SAR

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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