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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sarcoma Chemotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No