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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01192633
Recruitment Status : Unknown
Verified August 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : September 1, 2010
Last Update Posted : September 1, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Sarcoma Chemotherapy Drug: GVP Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase Ⅱ Study of Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
Study Start Date : January 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Intervention Details:
    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

Primary Outcome Measures :
  1. 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 Measures :
  1. Response Rate [ Time Frame: every 6 weeks ]
  2. Overall Survival [ Time Frame: 2 years ]
  3. Side Effects [ Time Frame: every 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01192633

Contact: Zhiguo Luo, PhD 862164175590 ext 8908

China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhiguo Luo, PhD         
Sub-Investigator: Zhiyu Chen, PhD         
Sponsors and Collaborators
Fudan University
Principal Investigator: Xiaonan Hong, MD Fudan University

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital Identifier: NCT01192633     History of Changes
Other Study ID Numbers: GVP-SAR
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: September 1, 2010
Last Verified: August 2010

Keywords provided by Fudan University:

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators