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

Phase 2

• Conditions: Sarcoma; Chemotherapy

• Registration Number: NCT01192633
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-03-25
• Status Verified: 2010-08
• Study First Submitted QC: 2010-08-31
• Last Update Submitted: 2010-08-31
• Study First Posted: 2010-09-01
• Last Update Posted: 2010-09-01
• Primary Completion: 2011-01
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Response Rate	every 6 weeks
Overall Survival	2 years
Side Effects	every 3 weeks

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China