Clinical trial NCT01192633: Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
Official title: Phase Ⅱ Study of Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sarcoma
Chemotherapy
Keywords: Sarcoma
gemcitabine
vincristine
cisplatin
chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2010-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
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.)
timeFrame: every 6 weeks
Secondary outcomes:
measure: Response Rate
timeFrame: every 6 weeks
measure: Overall Survival
timeFrame: 2 years
measure: Side Effects
timeFrame: every 3 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xiaonan Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.