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

Phase 2
18 Years
75 Years
Open (Enrolling)
Sarcoma, Chemotherapy

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Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

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.)

Outcome Time Frame:

every 6 weeks

Safety Issue:


Principal Investigator

Xiaonan Hong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

January 2009

Completion Date:

January 2011

Related Keywords:

  • Sarcoma
  • Chemotherapy
  • Sarcoma
  • gemcitabine
  • vincristine
  • cisplatin
  • chemotherapy
  • Sarcoma