A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

Osteosarcoma Clinical Trial

Official title:

A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01002092
• Other study ID #: SIM-65
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 25, 2009
• Last updated: August 31, 2014
• Start date: February 2009
• Est. completion date: December 2014

Study information

• Verified date: August 2014
• Source: Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis

• At least one measurable lesion

• Life expectancy > 3 months

• ECOG performance status 0-2

• Adequate hematologic, cardiac, renal, and hepatic function

• Patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study

Exclusion Criteria:

• Evidence of metastasis

• Serious infection

• Evidence of bleeding diathesis

• Significant cardiovascular disease

• Pregnant or lactating woman

• Allergic to E.coli preparation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• Chemotherapy
Week 1 day 1 MTX 8 g/m2; Week 3 day 1-2 CDP 100-120 mg/m2 day 1 ADM/THP 60 mg/m2; Week 5 day 1-6 IFO 2 g/day; Week 7 rest; Week 8 surgery; Two weeks after the surgery repeat the chemotherapy cycle 3 times (6 weeks per cycle).
• Endostar
In each cycle, Week 1-2 day 1-14 endostar 7.5 mg/m2/day; Week 5-6 day 1-14 endostar 7.5 mg/m2/day

Locations

Country	Name	City	State
China	The Military General Hospital of Beijing PLA	Beijing
China	General Hospital of Jinan Military Command	Jinan	Shandong
China	Nanjing General Hospital of Nanjing Military Command	Nanjing	Jiangsu
China	Xijing Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		5 years	No
Secondary	Limb Salvage Rate		end of the first cycle	No
Secondary	Overall Survival		5 years	No
Secondary	Clinical Response Rate		end of the first cycle	No
Secondary	Clinical Benefit Response		end of the first cycle	No
Secondary	Quality of Life		after 4 cycles	No