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A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

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ClinicalTrials.gov Identifier: NCT01002092
Recruitment Status : Unknown
Verified August 2014 by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd.
Recruitment status was:  Active, not recruiting
First Posted : October 27, 2009
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

October 25, 2009
October 27, 2009
September 3, 2014
February 2009
December 2014   (Final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01002092 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteosarcoma
  • 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).
  • Drug: 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
  • Active Comparator: Chemotherapy
    Intervention: Drug: Chemotherapy
  • Experimental: Endostar plus Chemotherapy
    Interventions:
    • Drug: Chemotherapy
    • Drug: Endostar
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
160
Same as current
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01002092
SIM-65
No
Not Provided
Not Provided
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Not Provided
Principal Investigator: Sujia Wu, Dr. Nanjing PLA General Hospital
Principal Investigator: Xin Shi, Dr. Nanjing PLA General Hospital
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP