Status:
UNKNOWN
Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
Lead Sponsor:
Fudan University
Conditions:
Sarcoma
Chemotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01192633
Start Date
January 1 2009
End Date
January 1 2011
Last Update
September 1 2010
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032