Chemotherapy, Sarcoma
Conditions
Keywords
Sarcoma, gemcitabine, vincristine, cisplatin, chemotherapy
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.
Interventions
DRUGGVP
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
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Response Rate | every 6 weeks |
| Overall Survival | 2 years |
| Side Effects | every 3 weeks |
Countries
China
Contacts
Primary ContactZhiguo Luo, PhD
Outcome results
None listed