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

Primary Purpose

Sarcoma, Chemotherapy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
GVP
Sponsored by
Fudan University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcoma focused on measuring Sarcoma, gemcitabine, vincristine, cisplatin, chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Cancer HospitalRecruiting

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Response Rate
Overall Survival
Side Effects

Full Information

First Posted
March 25, 2010
Last Updated
August 31, 2010
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01192633
Brief Title
Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
Acronym
GVPS
Official Title
Phase Ⅱ Study of Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Chemotherapy
Keywords
Sarcoma, gemcitabine, vincristine, cisplatin, chemotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GVP
Intervention Description
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
Primary Outcome Measure Information:
Title
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.)
Time Frame
every 6 weeks
Secondary Outcome Measure Information:
Title
Response Rate
Time Frame
every 6 weeks
Title
Overall Survival
Time Frame
2 years
Title
Side Effects
Time Frame
every 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiguo Luo, PhD
Phone
862164175590
Ext
8908
Email
luozhiguo88@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaonan Hong, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiguo Luo, PhD
First Name & Middle Initial & Last Name & Degree
Zhiyu Chen, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
11481354
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 Clin Oncol. 2001 Aug 1;19(15):3483-9. doi: 10.1200/JCO.2001.19.15.3483.
Results Reference
result
PubMed Identifier
16133789
Citation
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;24(3):249-53. doi: 10.1007/s10637-005-3537-1.
Results Reference
result
PubMed Identifier
26512574
Citation
Luo Z, Zhang X, Peng W, Wu X, Wang H, Yu H, Wang J, Chang J, Hong X. A Phase II Study of Gemcitabine, Vincristine, and Cisplatin As Second-Line Treatment for Patients with Advanced Soft Tissue Sarcoma. Medicine (Baltimore). 2015 Oct;94(43):e1777. doi: 10.1097/MD.0000000000001777.
Results Reference
derived

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

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