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

Sarcoma Clinical Trial

— GVPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01192633
• Other study ID #: GVP-SAR
• Status: Recruiting
• Phase: Phase 2
• First received: March 25, 2010
• Last updated: August 31, 2010
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: August 2010
• Source: Fudan University
• Contact: Zhiguo Luo, PhD
• Phone: 862164175590
• Email: luozhiguo88[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy
• Sarcoma

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (2)

Hartmann JT, Oechsle K, Huober J, Jakob A, Azemar M, Horger M, Kanz L, Bokemeyer C. An open label, non-comparative phase II study of gemcitabine as salvage treatment for patients with pretreated adult type soft tissue sarcoma. Invest New Drugs. 2006 May;2 — View Citation

Patel SR, Gandhi V, Jenkins J, Papadopolous N, Burgess MA, Plager C, Plunkett W, Benjamin RS. Phase II clinical investigation of gemcitabine in advanced soft tissue sarcomas and window evaluation of dose rate on gemcitabine triphosphate accumulation. J Cl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Response Rate		every 6 weeks	Yes
Secondary	Overall Survival		2 years	Yes
Secondary	Side Effects		every 3 weeks	Yes