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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01192633
First received: March 25, 2010
Last updated: August 31, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Sarcoma
Chemotherapy
Drug: GVP
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase Ⅱ Study of Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma

Resource links provided by NLM:


Further study details as provided by Fudan University:

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.) [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response Rate [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Side Effects [ Time Frame: every 3 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192633

Contacts
Contact: Zhiguo Luo, PhD 862164175590 ext 8908 luozhiguo88@yahoo.com.cn

Locations
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
Investigators
Principal Investigator: Xiaonan Hong, MD Fudan University
  More Information

Publications:
Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital
ClinicalTrials.gov Identifier: NCT01192633     History of Changes
Other Study ID Numbers: GVP-SAR
Study First Received: March 25, 2010
Last Updated: August 31, 2010
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Sarcoma
gemcitabine
vincristine
cisplatin
chemotherapy

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Vincristine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 18, 2014