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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sarcoma, Chemotherapy

Intervention / Treatment
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* Drug: GVP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GVP|Drug: gemcitabine, vincristine,cisplatin cisplatin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 vincristine 1.4mg/m2(less than 2 mg), iv, D1 repeat every 3 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival(Progression-free survival was evaluated for the period from the date of first treatment with this regimen to the date when disease progression was first observed or death occurred.) |  | every 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | every 6 weeks | 
| Overall Survival |  | 2 years | 
| Side Effects |  | every 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoma, gemcitabine, vincristine, cisplatin, chemotherapy