Overview

This trial is active, not recruiting.

Condition osteosarcoma
Treatments chemotherapy, endostar
Phase phase 2
Target VEGF
Sponsor Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Start date February 2009
End date December 2014
Trial size 160 participants
Trial identifier NCT01002092, SIM-65

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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).
(Experimental)
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

Primary Outcomes

Measure
Progression Free Survival
time frame: 5 years

Secondary Outcomes

Measure
Limb Salvage Rate
time frame: end of the first cycle
Overall Survival
time frame: 5 years
Clinical Response Rate
time frame: end of the first cycle
Clinical Benefit Response
time frame: end of the first cycle
Quality of Life
time frame: after 4 cycles

Eligibility Criteria

Male or female participants from 12 years up to 60 years old.

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

Additional Information

Official title A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Principal investigator Sujia Wu, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd.