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

NCT01192633 | Unknown Phase 2

• 1 other identifier: GVP-SAR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Chemotherapy

Keywords

Sarcoma; gemcitabine; vincristine; cisplatin; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.)

  every 6 weeks

Secondary Outcomes (3)

• Response Rate

  every 6 weeks

• Overall Survival

  2 years

• Side Effects

  every 3 weeks

Interventions

GVP DRUG

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 Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 11481354 RESULT

• 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.

  PMID: 16133789 RESULT

• 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.

  PMID: 26512574 DERIVED

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Xiaonan Hong, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiguo Luo, PhD

CONTACT

862164175590; luozhiguo88@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: September 1, 2010
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 1, 2010

Record last verified: 2010-08

Locations

CN (1)