Clinical trial · Interventional
Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
Phase Ⅱ Study of Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
NCT01192633CI-TRIAL-00003861GVPSunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GVP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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 (3)
- measure
- Response Rate
- timeFrame
- every 6 weeks
- measure
- Overall Survival
- timeFrame
- 2 years
- measure
- Side Effects
- timeFrame
- every 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTPatel 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. PMID 11481354
- RESULTHartmann 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. PMID 16133789
- DERIVEDLuo 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. PMID 26512574